Pepcid Complete — v2

Pepcid Complete

4 Views

Version

v2

Effective date

April 15, 2024

Original packager

Sections captured

19

Identifiers

Document ID
1626fa89-cec4-6467-e063-6294a90aa2a4
Set ID
ac3cd760-4615-117b-e053-2a95a90a8d42
Application numbers
NDA020958
Product NDCs
67751-202
Package NDCs
67751-202-01, 67751-202-02
Original packager NDCs
16837-298

Names & Manufacturers

Brand names
Pepcid Complete
Generic names
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE
Manufacturer names
Navajo Manufacturing Company Inc
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Histamine-2 Receptor Antagonist [EPC]
Pharmacologic class (CS)
Mechanism of action
Histamine H2 Receptor Antagonists [MoA]

Other identifiers

NUI
N0000000151, N0000175784
RxCUI
283641, 688892
UNII
5QZO15J2Z8, H0G9379FGK, NBZ3QY004S
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each chewable tablet) Purposes Famotidine 10 mg Acid reducer Calcium carbonate 800 mg Antacid Magnesium hydroxide 165 mg Antacid
Active Ingredient Table (1)

Sequence 1

Active ingredients (in each chewable tablet)Purposes
Famotidine 10 mgAcid reducer
Calcium carbonate 800 mgAntacid
Magnesium hydroxide 165 mgAntacid
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.
Do Not Use (1)

Sequence 1

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
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

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
Indications And Usage (1)

Sequence 1

Use relieves heartburn associated with acid indigestion and sour stomach
Keep Out Of Reach Of Children (1)

Sequence 1

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)
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL Pepcid Complete 1ct
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Active ingredients (in each chewable tablet) Purposes Famotidine 10 mg Acid reducer Calcium carbonate 800 mg Antacid Magnesium hydroxide 165 mg Antacid
Purpose Table (1)

Sequence 1

Active ingredients (in each chewable tablet)Purposes
Famotidine 10 mgAcid reducer
Calcium carbonate 800 mgAntacid
Magnesium hydroxide 165 mgAntacid
Questions (1)

Sequence 1

Questions or comments? call 1-800-755-4008 (toll-free) or 215-273-8755 (collect)
Spl Product Data Elements (1)

Sequence 1

Pepcid Complete Famotidine, Calcium carbonate, and Magnesium hydroxide CELLULOSE ACETATE STARCH, CORN CROSPOVIDONE (15 MPA.S AT 5%) DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 D&C RED NO. 7 ACACIA HYDROXYPROPYL CELLULOSE (70000 WAMW) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MALTODEXTRIN MINERAL OIL SUCRALOSE FAMOTIDINE FAMOTIDINE CALCIUM CARBONATE CARBONATE ION MAGNESIUM HYDROXIDE HYDROXIDE ION P
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Stop Use (1)

Sequence 1

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days
Storage And Handling (1)

Sequence 1

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 inner seal imprinted with "Sealed For Your Safety" is broken or missing
Warnings (1)

Sequence 1

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)

OpenFDA raw payload

{'application_number': ['NDA020958'],
 'brand_name': ['Pepcid Complete'],
 'generic_name': ['FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE'],
 'manufacturer_name': ['Navajo Manufacturing Company Inc'],
 'nui': ['N0000000151', 'N0000175784'],
 'original_packager_product_ndc': ['16837-298'],
 'package_ndc': ['67751-202-02', '67751-202-01'],
 'pharm_class_epc': ['Histamine-2 Receptor Antagonist [EPC]'],
 'pharm_class_moa': ['Histamine H2 Receptor Antagonists [MoA]'],
 'product_ndc': ['67751-202'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['283641', '688892'],
 'spl_id': ['1626fa89-cec4-6467-e063-6294a90aa2a4'],
 'spl_set_id': ['ac3cd760-4615-117b-e053-2a95a90a8d42'],
 'substance_name': ['CALCIUM CARBONATE', 'FAMOTIDINE', 'MAGNESIUM HYDROXIDE'],
 'unii': ['H0G9379FGK', '5QZO15J2Z8', 'NBZ3QY004S']}