Pepcid Complete
FDA Label NDC 52904-948

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Pepcid Complete (NDC 52904-948). 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

Other

Drug Facts

Repackaged and distributed by:
Select Corporation 1433 Wainwright Way,
Carrollton, TX 75007, 877-244-4400, M-F 9am-5pm,
from a product manufactured by
JOHNSON & JOHNSON CONSUMER INC.

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

Otc - Purpose

Active ingredients (in each chewable tablet)Purposes
Famotidine 10 mgAcid reducer
Calcium carbonate 800 mgAntacid
Magnesium hydroxide 165 mgAntacid

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
  • keep the carton. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
  • do not use if pouch is torn or damaged

Inactive Ingredients

cellulose acetate, corn starch, crospovidone, D&C red no.7 calcium lake, dextrose excipient, FD&C blue no.1aluminum lake, FD&C red no.40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearrate, maltodextrin, mineral oil, modified starch, sucralose

Questions Or Comments?

1-800-755-4008 (toll-free) or 215-273-8755 (collect)

Principal Display Panel - 20 Packet Carton

DUAL ACTION
Pepcid®
Complete®
Acid Reducer + Antacid

Famotidine 10mg–Acid reducer
Calcium carbonate 800mg–Antacid
Magnesium hydroxide 165mg–Antacid

Just One Tablet!
Relieves Heartburn Due
to Acid Indigestion

Berry Flavor

20
Packets of
1 Chewable
Tablet

Principal Display Panel (20 Packet Carton)

Principal Display Panel (20 Packet Carton)

* Please review the disclaimer below.