Pepcid Complete
Pepcid Complete
e874118f-b4fe-4c80-aece-99ea20e7e805
HUMAN OTC DRUG LABEL
Aug 7, 2025
Kenvue Brands LLC
DUNS: 118772437
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Famotidine, Calcium carbonate, and Magnesium hydroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (19)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 16837-298-25
DUAL ACTION
Pepcid ®
Complete
Famotidine 10 mg–Acid reducer
Calcium carbonate 800 mg–Antacid
Magnesium hydroxide 165 mg–Antacid
Just One Tablet!
Relieves Heartburn Due to Acid Indigestion
Berry Flavor
actual size
25 Chewable Tablets
INDICATIONS & USAGE SECTION
Use
relieves heartburn associated with acid indigestion and sour stomach
SPL UNCLASSIFIED SECTION
Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA
OTC - ACTIVE INGREDIENT SECTION
|
Active ingredients (in each chewable tablet) |
Purposes |
|---|---|
|
Famotidine 10 mg |
Acid reducer |
|
Calcium carbonate 800 mg |
Antacid |
|
Magnesium hydroxide 165 mg |
Antacid |
WARNINGS SECTION
Warnings
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 withlightheadedness, sweating, or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequentchest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- kidney disease
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
If pregnant or breast-feeding, ask a health professional before use.
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)
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
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 INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
call1-800-755-4008 (toll-free) or215-273-8755 (collect)