ADD CONDITION
Complete
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- Active ingredients
- Famotidine 10 mg
- Calcium Carbonate 800 mg
- Magnesium Hydroxide 165 mg
- Other brand names
- Acid Reducer Complete (by Safeway)
- Acid Reducer Complete (by Safeway)
- Acid Reducer Complete (by Walgreen Company)
- Acid Reducer Complete (by Walgreen Company)
- Acid Reducer Plus Antacid (by Cvs Pharmacy)
- Acid Reducer Plus Antacid (by Cvs Pharmacy)
- Acid Reducer Plus Antacid (by Rite Aid Corporation)
- Acid Reducer Plus Antacid (by Rite Aid Corporation)
- Basic Care Dual Action Complete (by Amazon. Com Services Llc)
- Careone Acid Reducer Complete (by American Sales Company)
- Careone Acid Reducer Complete (by American Sales Company)
- Dg Health Acid Reducer Complete (by Dolgencorp, Llc)
- Dual Action Complete (by H E B)
- Dual Action Complete (by H E B)
- Dual Action Complete (by Kroger Company)
- Dual Action Complete (by Kroger Company)
- Dual Action Complete (by Meijer Distribution Inc)
- Dual Action Complete (by Meijer Distribution Inc)
- Dual Action Complete (by Publix Super Markets Inc)
- Dual Action Pepcid Complete (by Lil' Drug Store Products, Inc.)
- Equaline Complete (by United Natural Foods, Inc. Dba Unfi)
- Equate Acid Reducer Complete (by Wal-Mart Stores Inc)
- Equate Acid Reducer Complete (by Wal-Mart Stores Inc)
- Foster and Thrive Acid Reducer Antacid (by Strategic Sourcing Services Llc)
- Good Neighbor Pharmacy Dual Action Complete (by Amerisource Bergen)
- Good Sense Dual Action Complete (by L. Perrigo Company)
- Injoy Heartburn Relief (by L. Perrigo Company)
- Injoy Heartburn Relief (by Sixarp, Llc)
- Leader Acid Reducer Complete (by Cardinal Health 110, Llc. Dba Leader)
- Leader Acid Reducer Complete (by Cardinal Health 110, Llc. Dba Leader)
- Pepcid Complete (by Kenvue Brands Llc)
- Pepcid Complete (by Kenvue Brands Llc)
- Pepcid Complete (by Kenvue Brands Llc)
- Pepcid Complete (by Select Corporation)
- Pepcid Complete, Pepcid Complete, Travel Basix (by Lil' Drug Store Products, Inc.)
- Signature Care Acid Reducer Complete (by Safeway)
- Signature Care Acid Reducer Complete (by Safeway)
- Topcare Dual Action Complete (by Topco Associates Llc)
- Topcare Dual Action Complete (by Topco Associates Llc)
- Up and up Dual Action Acid Reducer and Antacid (by Target Corporation)
- Up and up Dual Action Acid Reducer Antacid (by Target Corporation)
- View full label-group details →
- Drug classes
- Calculi Dissolution Agent, Histamine-2 Receptor Antagonist, Osmotic Laxative
- 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 2008
- Label revision date
- March 12, 2026
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Famotidine 10 mg
- Calcium Carbonate 800 mg
- Magnesium Hydroxide 165 mg
- Other brand names
- Acid Reducer Complete (by Safeway)
- Acid Reducer Complete (by Safeway)
- Acid Reducer Complete (by Walgreen Company)
- Acid Reducer Complete (by Walgreen Company)
- Acid Reducer Plus Antacid (by Cvs Pharmacy)
- Acid Reducer Plus Antacid (by Cvs Pharmacy)
- Acid Reducer Plus Antacid (by Rite Aid Corporation)
- Acid Reducer Plus Antacid (by Rite Aid Corporation)
- Basic Care Dual Action Complete (by Amazon. Com Services Llc)
- Careone Acid Reducer Complete (by American Sales Company)
- Careone Acid Reducer Complete (by American Sales Company)
- Dg Health Acid Reducer Complete (by Dolgencorp, Llc)
- Dual Action Complete (by H E B)
- Dual Action Complete (by H E B)
- Dual Action Complete (by Kroger Company)
- Dual Action Complete (by Kroger Company)
- Dual Action Complete (by Meijer Distribution Inc)
- Dual Action Complete (by Meijer Distribution Inc)
- Dual Action Complete (by Publix Super Markets Inc)
- Dual Action Pepcid Complete (by Lil' Drug Store Products, Inc.)
- Equaline Complete (by United Natural Foods, Inc. Dba Unfi)
- Equate Acid Reducer Complete (by Wal-Mart Stores Inc)
- Equate Acid Reducer Complete (by Wal-Mart Stores Inc)
- Foster and Thrive Acid Reducer Antacid (by Strategic Sourcing Services Llc)
- Good Neighbor Pharmacy Dual Action Complete (by Amerisource Bergen)
- Good Sense Dual Action Complete (by L. Perrigo Company)
- Injoy Heartburn Relief (by L. Perrigo Company)
- Injoy Heartburn Relief (by Sixarp, Llc)
- Leader Acid Reducer Complete (by Cardinal Health 110, Llc. Dba Leader)
- Leader Acid Reducer Complete (by Cardinal Health 110, Llc. Dba Leader)
- Pepcid Complete (by Kenvue Brands Llc)
- Pepcid Complete (by Kenvue Brands Llc)
- Pepcid Complete (by Kenvue Brands Llc)
- Pepcid Complete (by Select Corporation)
- Pepcid Complete, Pepcid Complete, Travel Basix (by Lil' Drug Store Products, Inc.)
- Signature Care Acid Reducer Complete (by Safeway)
- Signature Care Acid Reducer Complete (by Safeway)
- Topcare Dual Action Complete (by Topco Associates Llc)
- Topcare Dual Action Complete (by Topco Associates Llc)
- Up and up Dual Action Acid Reducer and Antacid (by Target Corporation)
- Up and up Dual Action Acid Reducer Antacid (by Target Corporation)
- View full label-group details →
- Drug classes
- Calculi Dissolution Agent, Histamine-2 Receptor Antagonist, Osmotic Laxative
- 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 2008
- Label revision date
- March 12, 2026
- Manufacturer
- HyVee Inc
- Registration number
- ANDA077355
- NDC root
- 42507-321
- 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
Hy•Vee® is a chewable tablet that combines the active ingredients famotidine (an acid reducer), calcium carbonate, and magnesium hydroxide (both of which are antacids). This dual-action formula is designed to relieve heartburn associated with acid indigestion and sour stomach, providing you with quick relief in a convenient berry-flavored tablet.
With just one tablet, you can effectively address heartburn symptoms, making it a practical option for managing occasional discomfort. Each bottle contains 50 chewable tablets, ensuring you have enough on hand when you need it.
Uses
If you're experiencing heartburn, which is a burning sensation in your chest often caused by acid indigestion or a sour stomach, this medication can help relieve those uncomfortable symptoms. It works by neutralizing stomach acid, providing you with quick relief so you can feel more comfortable. Whether it's after a heavy meal or due to certain foods, this treatment is designed to ease the discomfort associated with these digestive issues.
Dosage and Administration
If you are an adult or a child aged 12 years and older, it's important to chew the tablet completely before swallowing it. To help relieve your symptoms, you should chew one tablet before swallowing. However, make sure not to take more than two chewable tablets within a 24-hour period.
If you are caring for a child under 12 years old, please consult a doctor for guidance on the appropriate use of this medication.
What to Avoid
It's important to be cautious when considering this medication. You should not use it if you have difficulty swallowing food, are experiencing vomiting with blood, or have bloody or black stools, as these symptoms could indicate a serious health issue. In such cases, please consult your doctor immediately.
Additionally, avoid using this medication in combination with other acid reducers, as this can lead to unwanted effects. Always prioritize your health and safety by following these guidelines.
Side Effects
You should be aware of some important side effects and warnings associated with this medication. If you are allergic to famotidine or other acid reducers, do not use this product. Additionally, avoid using it if you have difficulty swallowing, are vomiting blood, or have bloody or black stools, as these could indicate a serious health issue that requires medical attention.
Before using this medication, consult your doctor if you have experienced heartburn for more than three months, or if you have heartburn accompanied by symptoms like lightheadedness, sweating, or chest pain. Other concerning signs include frequent wheezing, unexplained weight loss, nausea, vomiting, stomach pain, or if you have kidney disease. If your heartburn persists or worsens, or if you find yourself needing to use this product for more than 14 days, stop using it and seek medical advice.
Warnings and Precautions
You should not use this medication if you are allergic to famotidine or other acid reducers. Additionally, avoid using it if you have difficulty swallowing, are vomiting blood, or have bloody or black stools, as these could indicate a serious health issue. It's also important not to combine this medication with other acid reducers.
Before using this medication, consult your doctor if you have experienced heartburn for more than three months, have heartburn accompanied by dizziness or lightheadedness, or if you have chest pain, frequent wheezing, unexplained weight loss, or stomach pain. If you have kidney disease or are taking prescription medications, speak with your doctor or pharmacist first, as there may be interactions.
If your heartburn persists or worsens, or if you find you need to use this product for more than 14 days, stop using it and contact your doctor. In case of an overdose, seek emergency medical help immediately or call Poison Control at 1-800-222-1222.
Overdose
If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.
Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.
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 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the medication should be taken with care. Make sure they chew the tablet completely before swallowing it, as swallowing it whole is not recommended. To help relieve symptoms, they can chew one tablet, but be cautious not to exceed more than two chewable tablets in a 24-hour period. Always follow these guidelines to ensure safe use for your child.
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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.
Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.
Renal Impairment
If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize your kidney health and follow your doctor's guidance closely.
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 should be used if you have hepatic impairment (liver issues).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's important to be aware that some over-the-counter medications, like antacids and acid reducers, can interact with certain prescription drugs you may be taking. These interactions can affect how well your medications work or increase the risk of side effects.
To ensure your safety and the effectiveness of your treatment, always discuss any medications, including over-the-counter products, with your healthcare provider. They can help you understand potential interactions and make any necessary adjustments to your treatment plan.
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). It's important to keep it protected from moisture, as this can affect its effectiveness and safety.
When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them to ensure safe and responsible disposal.
Additional Information
You should take this medication orally. If you are an adult or a child aged 12 years and older, remember to chew the tablet completely before swallowing it. For symptom relief, chew one tablet, but do not exceed two chewable tablets in a 24-hour period. If the user is under 12 years old, consult a doctor for guidance.
If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Always keep it out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.
FAQ
What is Hy•Vee®?
Hy•Vee® is a chewable tablet that contains famotidine, calcium carbonate, and magnesium hydroxide, designed to relieve heartburn associated with acid indigestion and sour stomach.
How should I take Hy•Vee®?
For adults and children 12 years and over, chew 1 tablet completely before swallowing. Do not swallow the tablet whole and do not use more than 2 tablets in 24 hours.
What should I do if I have heartburn for more than 3 months?
You should ask a doctor, as this may be a sign of a more serious condition.
Are there any warnings associated with Hy•Vee®?
Yes, do not use if you are allergic to famotidine or other acid reducers, or if you have trouble swallowing food, vomiting with blood, or bloody or black stools.
Can I use Hy•Vee® if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using Hy•Vee®.
What should I do if my heartburn continues or worsens?
You should stop using Hy•Vee® and ask a doctor if your heartburn continues or worsens.
What are the side effects of Hy•Vee®?
Possible side effects include allergic reactions, and you should seek medical help if you experience severe symptoms or overdose.
Is Hy•Vee® safe for children under 12?
Children under 12 years should ask a doctor before using Hy•Vee®.
What should I do in case of overdose?
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Packaging Info
Below are the non-prescription pack sizes of Complete (famotidine, calcium carbonate and magnesium hydroxide). 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
| ||||
| Tablet, Chewable |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Complete, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
No description information is available for the specified drug.
Uses and Indications
This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach. It is intended for use in adults and pediatric patients as directed.
Dosage and Administration
Adults and children aged 12 years and over are advised to chew 1 tablet completely before swallowing to relieve symptoms. It is important that the tablet is not swallowed whole. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.
For children under 12 years of age, it is recommended to consult a physician before administration.
Contraindications
Use is contraindicated in patients who experience difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated due to the potential for increased risk of adverse effects.
Warnings and Precautions
Patients should be aware of the following warnings and precautions associated with the use of this medication.
Allergy Alert This medication should not be used by individuals who are allergic to famotidine or other acid reducers.
Contraindications The medication is contraindicated in patients experiencing difficulty or pain when swallowing food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition. Such patients should seek medical attention promptly. Additionally, this medication should not be used concurrently with other acid reducers.
Pre-Use Consultation Healthcare professionals should be consulted prior to use if the patient has experienced heartburn for more than three months, as this may suggest a more serious condition. Patients should also seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or if they have a history of kidney disease.
Drug Interactions Patients taking prescription medications should consult with their doctor or pharmacist before using this product, as antacids and acid reducers may interact with certain prescription drugs.
Monitoring and Discontinuation Patients are advised to discontinue use and consult a healthcare professional if heartburn persists or worsens, or if the medication is required for more than 14 days.
Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.
Side Effects
Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to seek medical attention if they experience any of the following symptoms: difficulty or pain when swallowing, vomiting that includes blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.
Patients should not use this medication if they have a known allergy to famotidine or other acid reducers. Additionally, it is contraindicated for use in conjunction with other acid reducers.
Before using this medication, patients should consult a healthcare professional if they have experienced heartburn for more than three months, as this may signal a more serious condition. Other symptoms that warrant medical consultation include heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or a history of kidney disease.
Patients are advised to discontinue use and consult a healthcare provider if their heartburn persists or worsens, or if they find it necessary to use the product for more than 14 days.
Drug Interactions
Antacids and acid reducers may interact with certain prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the therapeutic effects of these medications when co-administered with antacids or acid-reducing agents.
Healthcare professionals should consider adjusting the dosage of the affected prescription drugs based on clinical response and therapeutic drug monitoring, if applicable. Careful timing of administration may also be necessary to minimize interaction effects.
Packaging & NDC
Below are the non-prescription pack sizes of Complete (famotidine, calcium carbonate and magnesium hydroxide). 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
| ||||
| Tablet, Chewable |
| ||
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 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, it is important to note that the tablet must not be swallowed whole; it should be chewed completely before swallowing. To alleviate symptoms, patients in this age group may chew 1 tablet prior to swallowing, with a maximum dosage of 2 chewable tablets within a 24-hour period.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.
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
Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.
Overdosage
In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation.
Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.
Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.
Nonclinical Toxicology
If pregnant or breast-feeding, it is advised to consult a health professional before 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
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to inform patients that they should not use this medication if they experience difficulty or pain when swallowing food, vomiting blood, or have bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical evaluation.
Patients should be cautioned against using this product in conjunction with other acid reducers, as this may lead to adverse effects. They should be instructed to discontinue use and consult a doctor if their heartburn persists or worsens. Additionally, patients should be advised not to use this product for more than 14 days without consulting a healthcare professional.
Healthcare providers should encourage patients to seek medical advice before using this medication if they have experienced heartburn for over three months, as this may signal a more serious condition. Patients should also be informed to consult a doctor if they experience heartburn accompanied by lightheadedness, sweating, or dizziness, or if they have chest pain or shoulder pain along with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders.
Furthermore, patients should be advised to seek medical guidance if they experience frequent chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain. Those with a history of kidney disease should also consult a healthcare professional prior to use.
Lastly, patients should be reminded to speak with their doctor or pharmacist before using this medication if they are currently taking any prescription drugs, as antacids and acid reducers may interact with certain medications.
Storage and Handling
The product is supplied in a configuration that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Additionally, it is essential to protect the product from moisture to ensure optimal storage conditions. Proper handling and storage practices are crucial for preserving the quality of the product.
Additional Clinical Information
The medication is administered orally, with specific instructions for different age groups. Adults and children aged 12 years and older should chew one tablet completely before swallowing to relieve symptoms, with a maximum of two chewable tablets allowed within a 24-hour period. For children under 12 years, consultation with a doctor is advised prior to use.
Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.
Drug Information (PDF)
This file contains official product information for Complete, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.