PEPCID COMPLETE- famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable 
Navajo Manufacturing Company Inc

----------

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

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?

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

PRINCIPAL DISPLAY PANEL

Pepcid Complete 1ct

PEPCID COMPLETE 
famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-202(NDC:16837-298)
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)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ACACIA (UNII: 5C5403N26O)  
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)  
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:67751-202-022 in 1 CARTON08/06/2020
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67751-202-011 in 1 CARTON08/06/2020
21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02095808/06/2020
Labeler - Navajo Manufacturing Company Inc (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-202) , repack(67751-202)

Revised: 4/2024
Document Id: 1626fa89-cec4-6467-e063-6294a90aa2a4
Set id: ac3cd760-4615-117b-e053-2a95a90a8d42
Version: 2
Effective Time: 20240415
 
Navajo Manufacturing Company Inc