PEPCID COMPLETE- famotidine, calcium carbonate, magnesium hydroxide tablet, chewable 
JC World Bell Wholesale Co., Inc.

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Pepcid Complete

Drug Facts

Active ingredients (in each chewable tablet)

Famotidine 10 mg 
Calcium carbonate 800 mg 
Magnesium hydroxide 165 mg

Purposes

Acid reducer

Antacid

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

Other information

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

Questions or comments?

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

Package Labeling:50269-016-01

Outer Package2Inner Package2

Package Labeling:50269-016-02

Outer Package3Inner Package3

Package Labeling:Inner Package3

Label

PEPCID COMPLETE 
famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-016(NDC:16837-298)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
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)  
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize18mm
FlavorBERRYImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50269-016-016 in 1 BOX09/01/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50269-016-026 in 1 BOX09/01/2020
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50269-016-2525 in 1 BOX09/01/2020
31 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02095809/01/2020
Labeler - JC World Bell Wholesale Co., Inc. (805257581)
Establishment
NameAddressID/FEIBusiness Operations
Johnson & Johnson Consumer Inc.878046358manufacture(50269-016)
Establishment
NameAddressID/FEIBusiness Operations
JC World Bell Wholesale Co., Inc.805257581repack(50269-016)

Revised: 12/2023
Document Id: 0cf37e5a-d9db-7b3f-e063-6394a90a60d1
Set id: 39f7ee67-4eab-42b0-82fc-40dc8ce7666b
Version: 3
Effective Time: 20231220
 
JC World Bell Wholesale Co., Inc.