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Pepcid Complete by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Dosage form: tablet, chewable
Ingredients: famotidine 10mg, calcium carbonate 800mg, magnesium hydroxide 165mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 16837-891

Pepcid Complete

Drug Facts

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

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 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

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

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)

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 seal under bottle cap printed "SAFETY SEAL®" is open or torn

Inactive ingredients

cellulose acetate, corn starch, crospovidone, D&C yellow no. 10 aluminum lake, dextrose excipient, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 16837-891-50

DUAL ACTION
Pepcid
®
Complete

Famotidine–Acid reducer
Calcium carbonate–Antacid
Magnesium hydroxide–Antacid

Just One Tablet!
Relieves Heartburn Due to Acid Indigestion

50
Chewable Tablets
Mint Flavor

actual size

PEPCID COMPLETE 
famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16837-891
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
famotidine (famotidine) famotidine10 mg
calcium carbonate (carbonate ion) calcium carbonate800 mg
magnesium hydroxide (hydroxide ion) magnesium hydroxide165 mg
Inactive Ingredients
Ingredient NameStrength
cellulose acetate 
starch, corn 
crospovidone (15 MPA.S AT 5%) 
D&C yellow no. 10 
aluminum oxide 
Dextrose, Unspecified form 
FD&C blue no. 1 
acacia 
hydroxypropyl cellulose (80000 MW) 
hypromellose, unspecified 
lactose monohydrate 
magnesium stearate 
maltodextrin 
mineral oil 
sucralose 
Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize18mm
FlavorMINTImprint CodeP
Contains    
Packaging
#Item CodePackage Description
1NDC:16837-891-2525 TABLET, CHEWABLE in 1 BOTTLE
2NDC:16837-891-5050 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02095803/01/2009
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Medically reviewed on Oct 7, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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