Famotidine Tablet, Film Coated

Famotidine Tablet, Film Coated
SPL v4
SPL
SPL Set ID 4e5db906-992f-476b-9d97-63a4c582bbdc
Route
ORAL
Published
Effective Date 2022-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Microcrystalline Cellulose Starch, Corn Sodium Starch Glycolate Type A Hydroxypropyl Cellulose (110000 Wamw) Magnesium Stearate Hypromellose 2910 (6 Mpa.s) Titanium Dioxide Triacetin Polyethylene Glycol 4000 Talc

Identifiers & Packaging

Pill Appearance
Imprint: V;15 Shape: round Color: white Size: 5 mm Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2022-01-28
Description

Drug Facts

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

Drug Facts

Uses
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions
  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn
    • to preventsymptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes beforeeating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor
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
Allergy Alert

Do not use if you are allergic to famotidine or other acid reducers

Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° - 25°C (68° - 77°F)
  • protect from moisture
  • compares to the active ingredient in Zantac 360
Inactive Ingredients

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol

Questions Or Comments?

1 844-387-1231 (toll-free)

Stop Use and Ask A Doctor If
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Active Ingredient (in Each Tablet)

Famotidine USP, 10 mg and 20 mg

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
Package Label.principal Display Panel

Famotidine Tablets USP 10mg - NDC 71821-012-08 -Container Label

Famotidine Tablets USP 10mg - NDC 71821-012-08 -Pouch Label

Famotidine Tablets USP 20mg - NDC 71821-010-12 -Container Label

Famotidine Tablets USP 20mg - NDC 71821-010-12 -Pouch Label

Structured Label Content

Uses
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Acid reducer

Directions
  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn
    • to preventsymptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes beforeeating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor
Do Not Use (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
Allergy Alert (Allergy alert)

Do not use if you are allergic to famotidine or other acid reducers

Other Information (Other information)
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° - 25°C (68° - 77°F)
  • protect from moisture
  • compares to the active ingredient in Zantac 360
Inactive Ingredients (Inactive ingredients)

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol

Questions Or Comments? (Questions or comments?)

1 844-387-1231 (toll-free)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Famotidine USP, 10 mg and 20 mg

Ask A Doctor Before Use If You Have (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
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Famotidine Tablets USP 10mg - NDC 71821-012-08 -Container Label

Famotidine Tablets USP 10mg - NDC 71821-012-08 -Pouch Label

Famotidine Tablets USP 20mg - NDC 71821-010-12 -Container Label

Famotidine Tablets USP 20mg - NDC 71821-010-12 -Pouch Label

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:44.562089 · Updated: 2026-03-14T23:02:26.872598