Pepcid Complete Tablet, Chewable
FDA Label NDC 16837-246

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Pepcid Complete (NDC 16837-246). 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, 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, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Principal Display Panel (Pepcid 01)

Principal Display Panel (Pepcid 01)

* Please review the disclaimer below.