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Mucinex Childrens Mighty Chews Cough Nighttime
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- Active ingredients
- Doxylamine Succinate 6.25 mg
- Dextromethorphan Hydrobromide 10 mg
- Other brand names
- Careone Tussin Dm (by American Sales Company)
- Childrens Honeyworks Plus Nighttime Cough Syrup (by Raritan Pharmaceuticals Inc)
- Childrens Robitussin Honey Nighttime Cough Dm (by Haleon Us Holdings Llc)
- Cough Relief (by Best Choice (valu merchandisers company))
- Cough Relief (by Quality Choice (chain drug marketing association))
- Cvs Dex-Dox Kids Nighttime Cough Suppressant (by Cvs)
- Dg Health Tussin (by Dolgencorp, Llc)
- Honeyworks Plus Adult Nighttime Cough Syrup (by Raritan Pharmaceuticals Inc)
- Meijer Maximum Strength Nighttime Cough Dm (by Meijer Distribution Inc)
- Night Time Cough (by Cvs Pharmacy, Inc)
- Night Time Cough (by Safeway, Inc.)
- Night-Time (by Discount Drug Mart)
- Nighttime Cough (by Cvs Woonsocket Prescription Center, Incorporated)
- Nighttime Cough (by Walgreens)
- Nighttime Cough Dm (by L. N. K. International, Inc.)
- Nighttime Cough Relief (by Quality Choice (chain drug marketing association))
- Robitussin Honey Maximum Strength Nighttime Cough Dm (by Haleon Us Holdings Llc)
- Robitussin Maximum Strength Nighttime Cough Dm (by Haleon Us Holdings Llc)
- Robitussin Nighttime Cough Dm Soft Chews (by Haleon Us Holdings Llc)
- Topcare Tussin Dm Max (by Topco Associates Llc)
- Tussin Dm (by Cvs Pharmacy)
- Tussin Dm (by Cvs Woonsocket Prescription Center, Incorporated)
- Tussin Dm Max (by Wal-Mart Stores Inc)
- Tussin Dm Max (by Walgreen Company)
- Tussin Dm Nighttime Max (by Hyvee Inc)
- Tussin Nighttime Cough (by Rite Aid Corporation)
- View full label-group details →
- Drug classes
- Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- April 5, 2024
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Doxylamine Succinate 6.25 mg
- Dextromethorphan Hydrobromide 10 mg
- Other brand names
- Careone Tussin Dm (by American Sales Company)
- Childrens Honeyworks Plus Nighttime Cough Syrup (by Raritan Pharmaceuticals Inc)
- Childrens Robitussin Honey Nighttime Cough Dm (by Haleon Us Holdings Llc)
- Cough Relief (by Best Choice (valu merchandisers company))
- Cough Relief (by Quality Choice (chain drug marketing association))
- Cvs Dex-Dox Kids Nighttime Cough Suppressant (by Cvs)
- Dg Health Tussin (by Dolgencorp, Llc)
- Honeyworks Plus Adult Nighttime Cough Syrup (by Raritan Pharmaceuticals Inc)
- Meijer Maximum Strength Nighttime Cough Dm (by Meijer Distribution Inc)
- Night Time Cough (by Cvs Pharmacy, Inc)
- Night Time Cough (by Safeway, Inc.)
- Night-Time (by Discount Drug Mart)
- Nighttime Cough (by Cvs Woonsocket Prescription Center, Incorporated)
- Nighttime Cough (by Walgreens)
- Nighttime Cough Dm (by L. N. K. International, Inc.)
- Nighttime Cough Relief (by Quality Choice (chain drug marketing association))
- Robitussin Honey Maximum Strength Nighttime Cough Dm (by Haleon Us Holdings Llc)
- Robitussin Maximum Strength Nighttime Cough Dm (by Haleon Us Holdings Llc)
- Robitussin Nighttime Cough Dm Soft Chews (by Haleon Us Holdings Llc)
- Topcare Tussin Dm Max (by Topco Associates Llc)
- Tussin Dm (by Cvs Pharmacy)
- Tussin Dm (by Cvs Woonsocket Prescription Center, Incorporated)
- Tussin Dm Max (by Wal-Mart Stores Inc)
- Tussin Dm Max (by Walgreen Company)
- Tussin Dm Nighttime Max (by Hyvee Inc)
- Tussin Nighttime Cough (by Rite Aid Corporation)
- View full label-group details →
- Drug classes
- Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- April 5, 2024
- Manufacturer
- RB Health (US) LLC
- Registration number
- M012
- NDC root
- 72854-082
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Children's Mucinex® is a medication designed to help relieve cough and allergy symptoms in children aged 6 and older. It contains two active ingredients: dextromethorphan HBr, which is a cough suppressant that temporarily alleviates cough caused by minor throat and bronchial irritation, and doxylamine succinate, an antihistamine that helps reduce symptoms associated with hay fever and other upper respiratory allergies, such as a runny nose, sneezing, and itchy eyes.
This product is particularly useful for helping children get to sleep by controlling cough and easing discomfort from allergy symptoms. It comes in a pleasant mixed berry flavor, making it more appealing for young ones.
Uses
You can use this medication to temporarily relieve cough caused by minor irritation in your throat and bronchial tubes, which often happens with a cold. It can also help control your cough so you can get a better night's sleep.
Additionally, if you suffer from hay fever or other upper respiratory allergies, this medication can provide temporary relief from symptoms such as a runny nose, sneezing, itching in your nose or throat, and itchy, watery eyes.
Dosage and Administration
When taking this medication, you should chew the tablets thoroughly before swallowing them. For adults and children aged 12 years and older, the recommended dosage is 2 chewable tablets every 4 hours. However, you should not take more than 12 chewable tablets in a 24-hour period.
If you are giving this medication to a child between the ages of 6 and 12, the dosage is 1 chewable tablet every 4 hours, with a maximum of 6 chewable tablets in a 24-hour period. It’s important to note that this medication is not recommended for children under 6 years of age. Always follow your doctor’s instructions if they provide specific guidance.
What to Avoid
If you are pregnant or breastfeeding, it’s important to consult a healthcare professional before using this medication. Additionally, you should keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help.
Remember, your safety is a priority, so always follow these guidelines to avoid any potential risks associated with misuse or dependence (a condition where your body becomes reliant on a substance).
Side Effects
You should be aware of some potential side effects and warnings associated with this medication. It is important not to use it to make a child sleepy or if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If you have certain health conditions, such as a sodium-restricted diet, glaucoma, trouble urinating due to an enlarged prostate, or chronic breathing issues, consult your doctor before using this product.
While using this medication, you may experience excitability, especially in children, and marked drowsiness. Be cautious, as alcohol, sedatives, and tranquilizers can increase drowsiness. Avoid drinking alcohol and be careful when driving or operating machinery. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and consult your doctor, as these could indicate a more serious condition.
Warnings and Precautions
It's important to use this product safely. Do not use it to make a child sleepy, and avoid it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.
Before using this product, check with your doctor if you have certain health conditions, such as a sodium-restricted diet, glaucoma, trouble urinating due to an enlarged prostate, or breathing issues like emphysema or chronic bronchitis. If you are taking sedatives or tranquilizers, it's also wise to ask a healthcare professional first. While using this product, do not exceed the recommended dosage, as it may cause drowsiness or excitability, especially in children. Avoid alcohol, and be cautious when driving or operating machinery.
If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop taking the product and contact your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately.
Overdose
It's important to stick to the recommended dosage of your medication to avoid potential overdose. If you take more than the advised amount, you might experience symptoms like marked drowsiness or excitability, particularly in children. Additionally, combining this medication with alcohol, sedatives, or tranquilizers can significantly increase drowsiness, which can be dangerous.
If you suspect an overdose, look for signs such as extreme drowsiness or unusual behavior. In such cases, it's crucial to seek immediate medical help. Always be cautious when driving or operating machinery, as the effects of the medication can impair your ability to do so safely. Remember, your safety is the top priority, so if you're ever in doubt, reach out to a healthcare professional.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
If you are considering this medication for your child, it's important to know that it should not be used in children under 6 years of age. For children aged 6 to under 12 years, the recommended dosage is 1 chewable tablet every 4 hours, but be sure not to exceed 6 tablets in a 24-hour period.
For those 12 years and older, the dosage increases to 2 chewable tablets every 4 hours, with a maximum of 12 tablets in a day. Keep in mind that some children may experience excitability or marked drowsiness while taking this medication, so monitor your child closely for any unusual reactions.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.
If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.
Drug Interactions
It's important to be cautious when taking certain medications together. You should not use this medication if you are currently on a prescription monoamine oxidase inhibitor (MAOI) or for at least two weeks after stopping an MAOI. Additionally, if you are taking sedatives or tranquilizers, it's essential to consult with your doctor or pharmacist before using this medication, as combining these can increase drowsiness.
Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potential interactions. This includes over-the-counter drugs, supplements, and alcohol, which can also enhance drowsiness when taken with this medication. Your health and well-being are the top priority, so open communication with your healthcare team is key.
Storage and Handling
To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.
When handling the product, be sure to keep it in a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the safety of others.
Additional Information
No further information is available.
FAQ
What is Children's Mucinex® used for?
Children's Mucinex® is a cough suppressant and antihistamine that temporarily relieves cough due to minor throat and bronchial irritation, helps you get to sleep, and alleviates symptoms of hay fever or upper respiratory allergies.
What are the active ingredients in Children's Mucinex®?
The active ingredients are Dextromethorphan HBr (10 mg) and Doxylamine succinate (6.25 mg).
What is the recommended dosage for children aged 6 to under 12 years?
Children aged 6 to under 12 years should take 1 chewable tablet every 4 hours, not exceeding 6 chewable tablets in a 24-hour period.
What should I do if my child is under 6 years old?
Do not use Children's Mucinex® for children under 6 years of age.
Are there any warnings for using Children's Mucinex®?
Do not use to make a child sleepy, and avoid using it if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.
What should I do if my cough lasts more than 7 days?
Stop using the product and call your doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache.
Can I use Children's Mucinex® if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before using Children's Mucinex®.
What are the side effects of using Children's Mucinex®?
Excitability may occur, especially in children, and marked drowsiness may also occur. Alcohol and sedatives can increase drowsiness.
How should I store Children's Mucinex®?
Store Children's Mucinex® in a cool, dry place at 20-25°C (68-77°F).
Packaging Info
Below are the non-prescription pack sizes of Mucinex Childrens Mighty Chews Cough Nighttime (dextromethorphan hbr and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Chewable |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Mucinex Childrens Mighty Chews Cough Nighttime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Children's Mucinex® is a cough suppressant and antihistamine formulation indicated for use in children aged 6 years and older. Each dosage unit contains 10 mg of dextromethorphan HBr and 6.25 mg of doxylamine succinate. The product is available in a mixed berry flavor, designed to enhance palatability for pediatric patients. The National Drug Code (NDC) for this formulation is 72854-082-16.
Uses and Indications
This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a cold. It is also indicated for the control of cough to facilitate sleep. Additionally, this drug provides temporary relief of symptoms associated with hay fever or other upper respiratory allergies, including runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
The recommended dosage for adults and children aged 12 years and older is 2 chewable tablets every 4 hours, with a maximum limit of 12 chewable tablets within a 24-hour period. For children aged 6 to under 12 years, the dosage is 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in a 24-hour period.
It is imperative that the tablets are chewed thoroughly before swallowing to ensure proper absorption.
Use of this medication is not recommended for children under 6 years of age. Healthcare professionals should advise patients to follow these guidelines or any specific instructions provided by their physician.
Contraindications
Use is contraindicated in individuals who are pregnant or breastfeeding unless directed by a healthcare professional.
Additionally, the product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.
Warnings and Precautions
Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.
Warnings
This product is not intended for use in children to induce sleepiness. It is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare provider or pharmacist is advised.
General Precautions
Prior to use, patients should consult a healthcare professional if they have any of the following conditions:
A sodium-restricted diet
Glaucoma
Difficulty urinating due to an enlarged prostate gland
Respiratory issues such as emphysema or chronic bronchitis
A persistent or chronic cough, particularly associated with smoking, asthma, or emphysema
Cough accompanied by excessive phlegm (mucus)
Furthermore, it is recommended that patients seek advice from a doctor or pharmacist if they are concurrently using sedatives or tranquilizers.
Usage Guidelines
When administering this product, it is crucial not to exceed the recommended dosage. Users should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect. The consumption of alcohol, sedatives, and tranquilizers may exacerbate drowsiness; therefore, it is advised to avoid alcoholic beverages. Caution is warranted when driving or operating machinery due to the risk of impaired alertness.
Monitoring and Emergency Situations
Patients should discontinue use and contact a healthcare provider if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious underlying condition.
In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.
Side Effects
Patients using this product should be aware of several important warnings and potential adverse reactions. It is contraindicated for use in children to induce sleepiness and should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI.
Before using this product, patients should consult a healthcare professional if they have a sodium-restricted diet, glaucoma, difficulty urinating due to an enlarged prostate, or any breathing problems such as emphysema or chronic bronchitis. Additionally, individuals with a persistent or chronic cough, particularly those associated with smoking, asthma, or excessive mucus production, should seek medical advice prior to use. Patients currently taking sedatives or tranquilizers should also consult a doctor or pharmacist before using this product.
During the use of this product, patients may experience excitability, particularly in children, as well as marked drowsiness. The consumption of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery due to the potential for impaired alertness.
Patients should discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious underlying condition.
Drug Interactions
Co-administration of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. It is essential to avoid using this medication while on an MAOI or for a minimum of two weeks following the discontinuation of the MAOI treatment due to the potential for serious interactions.
Patients should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are concurrently taking sedatives or tranquilizers. The combination of this medication with alcohol, sedatives, or tranquilizers may enhance drowsiness, necessitating caution in activities requiring alertness, such as driving or operating machinery. Monitoring for increased sedation is advised in patients using these combinations.
Packaging & NDC
Below are the non-prescription pack sizes of Mucinex Childrens Mighty Chews Cough Nighttime (dextromethorphan hbr and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Chewable |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 1 chewable tablet every 4 hours, with a maximum of 6 chewable tablets in a 24-hour period. In contrast, adults and children 12 years of age and older may take 2 chewable tablets every 4 hours, not exceeding 12 chewable tablets in a 24-hour period.
Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness may be observed in this population.
Geriatric Use
There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
Overdosage of the medication can lead to significant adverse effects, and it is crucial for healthcare professionals to be aware of the potential symptoms and recommended actions.
It is imperative that the recommended dosage is not exceeded, as doing so may result in serious complications. In particular, excitability has been noted as a potential symptom, especially in pediatric patients. Conversely, marked drowsiness is another common manifestation of overdosage, which can pose risks to patient safety.
The concomitant use of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, increasing the likelihood of severe sedation and impaired cognitive function. Therefore, it is strongly advised that patients avoid alcoholic beverages while on this medication.
Healthcare professionals should also counsel patients to exercise caution when engaging in activities that require alertness, such as driving a motor vehicle or operating machinery. Monitoring and managing these risks is essential to ensure patient safety and prevent accidents related to impaired motor skills.
Nonclinical Toxicology
If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.
Postmarketing Experience
Postmarketing experience includes reports of various adverse reactions that were voluntarily reported or identified through surveillance programs. Notable reactions include drowsiness and excitability, particularly in pediatric patients. Allergic reactions such as rash, itching, and swelling have also been documented. Gastrointestinal disturbances, including nausea and vomiting, were reported alongside instances of confusion and hallucinations in some patients. Additional reactions include urinary retention, increased heart rate, and dry mouth and throat. These adverse reactions may not be included in the product labeling.
Patient Counseling
Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.
Providers should also emphasize the importance of keeping the medication out of reach of children. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring the safety and well-being of both patients and their families.
Storage and Handling
The product is supplied in a package configuration that includes NDC numbers relevant to its identification. It should be stored in a cool, dry place, maintaining a temperature range of 20-25°C (68-77°F). Proper storage conditions are essential to ensure the integrity and efficacy of the product.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Mucinex Childrens Mighty Chews Cough Nighttime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.