Label: PEPCID COMPLETE- famotidine, calcium carbonate, magnesium hydroxide chewable tablet tablet, chewable
PEPCID COMPLETE, TRAVEL BASIX- famotidine, calcium carbonate, magnesium hydroxide chewable tablet tablet, chewable
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NDC Code(s):
66715-6422-7,
66715-6422-8,
66715-6522-2,
66715-7822-2, view more66715-9822-2, 66715-9822-3, 66715-9822-8
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each chewable tablet)
- Purposes
- Use
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Warnings
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.
- Directions
- Other information
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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?
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INGREDIENTS AND APPEARANCE
PEPCID COMPLETE
famotidine, calcium carbonate, magnesium hydroxide chewable tablet tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9822 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 165 mg FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 800 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) CELLULOSE ACETATE (UNII: 3J2P07GVB6) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) D&C RED NO. 7 (UNII: ECW0LZ41X8) MINERAL OIL (UNII: T5L8T28FGP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color purple Score no score Shape ROUND Size 18mm Flavor BERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9822-2 2 in 1 CARTON 07/17/2020 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9822-8 5 in 1 CARTON 09/02/2020 04/16/2024 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:66715-9822-3 3 in 1 CARTON 04/07/2022 3 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020958 07/17/2020 PEPCID COMPLETE, TRAVEL BASIX
famotidine, calcium carbonate, magnesium hydroxide chewable tablet tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6522 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 165 mg FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 800 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) CELLULOSE ACETATE (UNII: 3J2P07GVB6) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) D&C RED NO. 7 (UNII: ECW0LZ41X8) MINERAL OIL (UNII: T5L8T28FGP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color purple Score no score Shape ROUND Size 18mm Flavor BERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6522-2 2 in 1 CARTON 05/06/2022 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020958 05/06/2022 PEPCID COMPLETE, TRAVEL BASIX
famotidine, calcium carbonate, magnesium hydroxide chewable tablet tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-7822 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 165 mg FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 800 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) CELLULOSE ACETATE (UNII: 3J2P07GVB6) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) D&C RED NO. 7 (UNII: ECW0LZ41X8) MINERAL OIL (UNII: T5L8T28FGP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color purple Score no score Shape ROUND Size 18mm Flavor BERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-7822-2 2 in 1 CARTON 11/29/2022 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020958 11/29/2022 PEPCID COMPLETE
famotidine, calcium carbonate, magnesium hydroxide chewable tablet tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6422 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 165 mg FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 800 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) CELLULOSE ACETATE (UNII: 3J2P07GVB6) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) D&C RED NO. 7 (UNII: ECW0LZ41X8) MINERAL OIL (UNII: T5L8T28FGP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color purple Score no score Shape ROUND Size 18mm Flavor BERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6422-7 25 in 1 BOX, UNIT-DOSE 04/19/2022 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-6422-8 30 in 1 BOX, UNIT-DOSE 04/19/2022 2 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020958 04/19/2022 Labeler - Lil' Drug Store Products, Inc. (093103646)