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999 Cold Remedy
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This product has been discontinued
- Active ingredients
- Chlorpheniramine Maleate 2 mg/6000 mg
- Acetaminophen 100 mg/6000 mg
- Other brand names
- 999 Cold Remedy Granular (by China Resources Sanjiu Medical & Pharmaceutical Co Ltd)
- Cold and Flu Hbp (by Cvs Pharmacy)
- Cold and Flu Hbp (by Kroger Company)
- Cold and Flu Hbp (by Meijer Distribution Inc)
- Cold and Flu Hbp (by Walmart Inc.)
- Cold and Flu Hbp (by Winco Foods, Llc)
- Coricidin Hbp (by Bayer Healthcare Llc.)
- Ganmaoling (by Anhui Dongshengyoubang Pharmaceutical Co. , Ltd.)
- Yinchiao (by Anhui Dongshengyoubang Pharmaceutical Co. , Ltd.)
- View full label-group details →
- Dosage form
- Capsule
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2003
- Label revision date
- September 17, 2013
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Chlorpheniramine Maleate 2 mg/6000 mg
- Acetaminophen 100 mg/6000 mg
- Other brand names
- 999 Cold Remedy Granular (by China Resources Sanjiu Medical & Pharmaceutical Co Ltd)
- Cold and Flu Hbp (by Cvs Pharmacy)
- Cold and Flu Hbp (by Kroger Company)
- Cold and Flu Hbp (by Meijer Distribution Inc)
- Cold and Flu Hbp (by Walmart Inc.)
- Cold and Flu Hbp (by Winco Foods, Llc)
- Coricidin Hbp (by Bayer Healthcare Llc.)
- Ganmaoling (by Anhui Dongshengyoubang Pharmaceutical Co. , Ltd.)
- Yinchiao (by Anhui Dongshengyoubang Pharmaceutical Co. , Ltd.)
- View full label-group details →
- Dosage form
- Capsule
- 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 2003
- Label revision date
- September 17, 2013
- Manufacturer
- China Resources Sanjiu Medical & Pharmaceutical Co Ltd
- Registration number
- part343
- NDC root
- 12753-305
- 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
This medication is designed to temporarily relieve symptoms associated with the common cold, hay fever, or other upper respiratory allergies. If you're experiencing discomfort from minor aches and pains, headaches, sneezing, runny nose, sore throat, or itchy, watery eyes, this drug can help alleviate those symptoms. It may also provide relief from muscular aches and fever, making it a supportive option when you're feeling under the weather.
Uses
If you're dealing with the discomfort of a common cold, hay fever, or other upper respiratory allergies, this medication can help. It temporarily relieves a variety of bothersome symptoms, including minor aches and pains, headaches, and sore throats. You may also find relief from itchy, watery eyes, sneezing, a runny nose, and itching in your nose or throat. Additionally, it can help reduce fever, making you feel more comfortable as you recover.
Dosage and Administration
If you are an adult or a child aged 12 years and older, you should take 2 capsules each time, three times a day. This means you will be taking a total of 6 capsules daily. It’s important to follow this schedule to ensure the medication works effectively.
For children under 8 years of age, it’s crucial to consult a doctor before using this medication. The doctor will provide guidance on the appropriate dosage and whether it’s suitable for your child. Always make sure to follow their advice for the best results.
What to Avoid
It's important to use this medication safely. Keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately.
You should stop using the medication and consult a doctor if your pain or fever persists or worsens, if you notice any redness or swelling, or if your symptoms last longer than 7 days. Additionally, if you experience new symptoms like a rash, nausea, or vomiting, it's crucial to seek medical advice.
Side Effects
You should be aware of some important side effects and warnings associated with this medication. If your pain lasts more than 10 days or if you have a fever that persists for more than 3 days, you should stop using the medication and consult a doctor. Additionally, seek medical advice if your pain or fever worsens, if you notice any redness or swelling, or if new symptoms like a rash, nausea, or vomiting develop.
It's also important to talk to your doctor before using this medication if you have glaucoma, breathing issues such as emphysema or chronic bronchitis, or difficulty urinating due to an enlarged prostate. If you are taking sedatives or tranquilizers, consult with your doctor or pharmacist before use.
Warnings and Precautions
If you are using this medication, please be aware of some important warnings. Do not continue using it if your pain lasts more than 10 days or if your fever persists for more than 3 days. These could be signs of a more serious condition that needs medical attention.
You should stop using the medication and consult your doctor if your pain or fever worsens or does not improve after 7 days. Additionally, seek medical advice if you notice any redness or swelling, or if you develop new symptoms such as a rash, nausea, or vomiting.
In case of an overdose, it is crucial to get emergency medical help immediately or contact a Poison Control Center. This is important for both adults and children, even if there are no noticeable signs or symptoms. Your health and safety are the top priority.
Overdose
If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While specific signs of overdose are not detailed, common symptoms may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.
In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide healthcare professionals with as much information as possible about the medication taken and the amount. Remember, acting quickly can make a significant difference in your safety and health.
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 have a child under 8 years old, it's important to consult a doctor before using this medication. This is to ensure it's safe and appropriate for their specific needs. Additionally, be aware that this medication may cause excitability, particularly in children, so monitor your child for any unusual behavior after taking it. Always prioritize their safety and well-being by following these guidelines.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly. If your creatinine clearance (a measure of kidney function) falls below a certain level, your healthcare provider may recommend a reduced dose to avoid potential complications. Always discuss any concerns with your doctor to ensure your treatment is safe and effective.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).
Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.
Drug Interactions
It's important to be aware that certain medications can interact with each other, which may affect how they work or increase side effects. For instance, if you are taking this medication along with alcohol, sedatives, or tranquilizers, you might experience increased drowsiness. To ensure your safety and the effectiveness of your treatment, always consult with your healthcare provider or pharmacist before starting any new medications, especially if you are already using sedatives or tranquilizers.
Additionally, there are no specific laboratory test interactions noted, but it's still a good practice to discuss any tests you may undergo with your healthcare provider. Open communication about all medications and tests is key to managing your health effectively.
Storage and Handling
To ensure the safety and effectiveness of your product, store it in a dry place away from light and excessive heat. It's important to keep the container tightly closed when not in use to prevent contamination and maintain its quality. Following these simple storage guidelines will help you use the product safely and effectively.
Additional Information
No further information is available.
FAQ
What symptoms does this drug temporarily relieve?
This drug temporarily relieves symptoms associated with the common cold, hay fever, or other upper respiratory allergies, including minor aches and pains, headache, itchy watery eyes, sneezing, runny nose, sore throat, and fever.
What is the recommended dosage for adults and children 12 years and older?
Adults and children 12 years of age and older should take 2 capsules three times a day.
What should I do if I have children under 8 years of age?
Consult a doctor before using this drug for children under 8 years of age.
Are there any warnings I should be aware of?
Do not use this drug if pain lasts more than 10 days or if fever lasts more than 3 days. Consult a doctor if symptoms persist or worsen.
What should I do in case of an overdose?
In case of overdose, get medical help or contact a Poison Control Center right away.
Can this drug cause drowsiness?
Yes, this drug may cause drowsiness, especially if used with alcohol, sedatives, or tranquilizers. Consult a doctor or pharmacist if you are taking these substances.
Is it safe to use this drug if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before using this drug.
What should I do if new symptoms occur?
Stop use and consult a doctor if new symptoms occur, such as rash, nausea, or vomiting.
How should I store this drug?
Store the drug in a dry place, protect it from light and excessive heat, and keep it tightly closed.
Packaging Info
Below are the non-prescription pack sizes of 999 Cold Remedy (acetaminophen, chlorpheniramine maleate, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Capsule |
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Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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Drug Information (PDF)
This file contains official product information for 999 Cold Remedy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
The product is identified by the SPL code 34089-3. No specific description details are provided in the text.
Uses and Indications
This drug is indicated for the temporary relief of symptoms associated with the common cold, hay fever, or other upper respiratory allergies. The symptoms alleviated by this medication include minor aches and pains, headache, itchy and watery eyes, muscular aches, sneezing, runny nose, sore throat, and itching of the nose or throat. Additionally, it provides relief from fever.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Adults and children 12 years of age and older are advised to take 2 capsules at each administration, with a frequency of three times per day. For children under 8 years of age, it is recommended to consult a healthcare professional prior to use to determine appropriate dosing and safety considerations.
Contraindications
Use of this product is contraindicated in the following situations:
The product should be kept out of reach of children to prevent accidental ingestion.
In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is required.
Discontinue use and consult a healthcare professional if pain or fever persists or worsens.
Discontinue use and seek medical advice if redness or swelling occurs.
If symptoms last longer than 7 days, medical consultation is necessary.
New symptoms such as rash, nausea, or vomiting warrant discontinuation of use and consultation with a healthcare provider.
Warnings and Precautions
Patients should not use this medication if pain persists for more than 10 days or if fever lasts longer than 3 days. These conditions may indicate a more serious underlying issue that requires medical evaluation.
Healthcare professionals should advise patients to discontinue use and seek medical consultation if any of the following occur: pain or fever persists or worsens; redness or swelling is observed; symptoms continue for more than 7 days; or if new symptoms arise, including rash, nausea, or vomiting. These signs may suggest complications that necessitate further investigation.
In the event of an overdose, it is imperative to obtain emergency medical assistance immediately or contact a Poison Control Center. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms, to mitigate potential health risks associated with overdose.
Side Effects
Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to discontinue use and consult a healthcare professional if pain or fever persists or worsens, if redness or swelling is present, or if symptoms last for more than 7 days. Additionally, the emergence of new symptoms such as rash, nausea, or vomiting should prompt a consultation with a doctor.
Warnings indicate that the medication should not be used if pain lasts more than 10 days or if fever persists for more than 3 days. These guidelines are crucial for ensuring patient safety and preventing complications.
Patients with specific pre-existing conditions should exercise caution. It is recommended that individuals with glaucoma, breathing problems such as emphysema or chronic bronchitis, or difficulty in urination due to prostate gland enlargement consult a doctor before use. Furthermore, those taking sedatives or tranquilizers should seek advice from a healthcare professional or pharmacist prior to using this medication.
Overall, careful monitoring of symptoms and adherence to the outlined precautions can help mitigate the risk of adverse reactions.
Drug Interactions
Concurrent use of this medication with alcohol, sedatives, or tranquilizers may enhance the sedative effects, leading to increased drowsiness. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication in conjunction with sedatives or tranquilizers to ensure safe and effective use.
No specific interactions with laboratory tests have been identified in the available data.
Packaging & NDC
Below are the non-prescription pack sizes of 999 Cold Remedy (acetaminophen, chlorpheniramine maleate, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Capsule |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 8 years of age should consult a healthcare professional prior to use. There is a potential for excitability associated with the use of this medication, particularly in children. Caution is advised when administering to 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.
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
Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with a creatinine clearance less than the specified threshold.
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
In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to standard protocols for managing potential cases of drug overdose.
It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.
In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.
Additionally, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific management strategies tailored to the substance involved.
Documentation of the incident, including the amount ingested and the time of exposure, is vital for effective treatment and follow-up care.
Nonclinical Toxicology
If pregnant or breastfeeding, it is advised to consult a health professional prior to use.
The substance may induce excitability, particularly in pediatric populations. Additionally, drowsiness may occur when the substance is used concurrently with alcohol, sedatives, or tranquilizers.
No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.
Postmarketing Experience
Postmarketing experience has identified the following adverse reactions: excitability, particularly in children, and drowsiness when the product is used in conjunction with alcohol, sedatives, or tranquilizers. These events were reported voluntarily or through surveillance programs.
Patient Counseling
Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.
Patients should be instructed to monitor their symptoms closely and to report to their healthcare provider if pain or fever persists or worsens. Additionally, they should be aware of any redness or swelling that may occur and to seek medical advice if symptoms last longer than 7 days. Patients should also be vigilant for the emergence of new symptoms, such as rash, nausea, or vomiting, and report these to their healthcare provider.
It is essential to inform patients that the medication may cause excitability, particularly in children, and that drowsiness may occur, especially when used in conjunction with alcohol, sedatives, or tranquilizers. Therefore, patients should be cautioned about the potential effects on their ability to drive a motor vehicle or operate machinery.
Healthcare providers should encourage patients to consult with their doctor before using the medication if they have glaucoma, breathing problems such as emphysema or chronic bronchitis, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to speak with their doctor or pharmacist if they are currently taking sedatives or tranquilizers to ensure safe use of the medication.
Storage and Handling
The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to protect the product from light and excessive heat to maintain its efficacy. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be stored in a dry place to avoid moisture-related issues. Proper adherence to these storage conditions is crucial for ensuring the product's quality and effectiveness.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for 999 Cold Remedy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.