FDA Label for Pepcid Complete
View Indications, Usage & Precautions
Pepcid Complete Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids 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
- contains FD&C yellow no. 5 (tartrazine) as a color additive
- 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 seal under bottle cap printed "SAFETY SEAL®" is open or torn
Inactive Ingredients
cellulose acetate, corn starch, corn syrup solids, crospovidone, dextrose excipient, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, sucralose, triacetin
Questions Or Comments?
call 1-800-755-4008 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NDC 16837-246-25
DUAL ACTION
Pepcid®
Complete
Famotidine–Acid reducer
Calcium carbonate–Antacid
Magnesium hydroxide–Antacid
Just One Tablet!
Relieves Heartburn Due to Acid Indigestion
actual size
25
Chewable Tablets
Tropical Fruit Flavor
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