Famotidine 40 mg Tablets — Generic For Pepcid — Camber

These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS.

FAMOTIDINE tablets, for oral use

Initial U.S. Approval: 1986

Indications And Usage

Famotidine tablets are a histamine-2 (H

2) receptor antagonist indicated (

1):

In adult and pediatric patients 40 kg and greater for the treatment of:

In adults for the:

Dosage And Administration

IndicationRecommended Dosage (

2.1)

Adult and Pediatric Patients40 kg and greater

Active DU40 mg once daily; or 20 mg twice daily

Active Gastric Ulcer40 mg once daily

GERD 20 mg twice daily

Erosive Esophagitis20 mg twice daily; or 40 mg twice daily

Adults

Pathological Hypersecretory Conditions20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours

Risk Reduction of DU

Recurrence

20 mg once daily

2.1,

2.2)

Administration (

2.3):

Dosage Forms And Strengths

Tablets: 20 mg, 40 mg (

3)

Contraindications

History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H

2 receptor antagonists. (

4)

Warnings And Precautions

• Central Nervous System (CNS)

• Central Nervous System (CNS)

2.2,

5.1,

8.5,

8.6)

5.2)

Adverse Reactions

The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. (

6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

7.1)

7.2)

Use In Specific Populations

2.2,

5.1,

8.5)

2.2,

8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2021