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Drug Facts
Repackaged by:
Morning Star OTC
145 S. Anderson St, Los Angeles,
CA 90033
Pepcid Complete Tablet, Chewable
FDA Label NDC 53209-4001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Morning Star Otc for the product Pepcid Complete (NDC 53209-4001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, use, allergy alert, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each chewable tablet) | Purposes |
|---|---|
| Famotidine 10 mg | Acid reducer |
| Calcium carbonate 800 mg | Antacid |
| Magnesium hydroxide 165 mg | Antacid |
Use
relieves heartburn associated with acid indigestion and sour stomach
Allergy Alert
Do not use if you are allergic to famotidine or other acid reducers
Do Not Use
- if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
- with other acid reducers
Ask A Doctor Before Use If You Have
- had heartburn over 3 months. This may be a sign of a more serious condition.
- heartburn with lightheadedness, sweating, or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- kidney disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.
Stop Use And Ask A Doctor If
- your heartburn continues or worsens
- you need to take this product for more than 14 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- adults and children 12 years and over:
- do not swallow tablet whole: chew completely
- to relieve symptoms, chew 1 tablet before swallowing
- do not use more than 2 chewable tablets in 24 hours
- children under 12 years: ask a doctor
Other Information
- each tablet contains: calcium 320 mg, magnesium 70 mg
- read the directions and warnings before use
- read the bottle. It contains important information.
- store at 20°-25°C (68°-77°F)
- protect from moisture
- do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
Inactive Ingredients
cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose
Questions Or Comments?
call 1-800-755-4008(toll-free) or 215-273-8755(collect)
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