PEPCID COMPLETE- famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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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
  • 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)

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 inner seal imprinted with "SAFETY SEAL®" is broken or missing

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
See New Warnings

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
Tropical Fruit Flavor

actual size

25
Chewable Tablets

Principal Display Panel
PEPCID COMPLETE 
famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16837-246
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
STARCH, CORN (UNII: O8232NY3SJ)  
CORN SYRUP (UNII: 9G5L16BK6N)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ACACIA (UNII: 5C5403N26O)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MINERAL OIL (UNII: T5L8T28FGP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize17mm
FlavorFRUIT (Tropical Fruit Flavor) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16837-246-055 in 1 CARTON01/01/200903/31/2013
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:16837-246-088 in 1 CARTON01/01/200903/31/2012
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC:16837-246-2525 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2009
4NDC:16837-246-2625 in 1 TRAY01/01/200904/11/2016
41 in 1 POUCH; Type 0: Not a Combination Product
5NDC:16837-246-272500 in 1 TRAY01/01/200903/31/2014
51 in 1 POUCH; Type 0: Not a Combination Product
6NDC:16837-246-282500 in 1 TRAY01/01/200903/31/2013
61 in 1 POUCH; Type 0: Not a Combination Product
7NDC:16837-246-2925 in 1 TRAY01/01/200905/31/2013
71 in 1 POUCH; Type 0: Not a Combination Product
8NDC:16837-246-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2009
9NDC:16837-246-361 in 1 CARTON01/01/200901/24/2014
935 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10NDC:16837-246-6465 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200903/24/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02095801/01/2009
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 10/2021
Document Id: ce3425a0-2b7b-5d25-e053-2995a90afdae
Set id: 37e6a3f6-5261-475d-a7d4-e72854088982
Version: 7
Effective Time: 20211012
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division