Famotidine Tablets Usp, 10 Mg And 20 Mg

Famotidine Tablets Usp, 10 Mg And 20 Mg
SPL v2
SPL
SPL Set ID ebe3ca30-df25-4c56-8935-414a3431b5b9
Route
ORAL
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Microcrystalline Cellulose 101 Starch, Corn Sodium Starch Glycolate Type A Potato Hypromellose 2910 (5 Mpa.s) Microcrystalline Cellulose 102 Magnesium Stearate Hypromellose 2910 (15 Mpa.s) Hydroxypropyl Cellulose, Unspecified Titanium Dioxide Talc Carnauba Wax Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: T;11 Shape: round Color: white Color: yellow Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2021-11-08
Description

Famotidine USP 10 mg and 20 mg

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

Famotidine USP 10 mg and 20 mg

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

Warnings

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

Directions

• adults and children 12 years and over:

• to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

10 mg:

• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn

20 mg:

• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating 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

Other Information

• read the directions and warnings before use

• keep the carton. It contains important information.

• store at 20° to 25°C (68° to 77°F)

• protect from moisture

Inactive Ingredients


corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and film coating contains carnauba wax, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide; and additionally 20 mg contains iron oxide red and iron oxide yellow.

Questions Or Comments?

1-866-495-1995

Principal Display Panel


Famotidine Tablets USP 10 mg - 30s container label

 







Famotidine Tablets USP 10 mg - 30s container carton label

   





Famotidine Tablets USP 10 mg - 10 (1x10) blister carton label

 







Famotidine Tablets USP 20 mg - 30s container label

 







Famotidine Tablets USP 20 mg - 30s container carton label









Famotidine Tablets USP 20 mg - 10 (1x10) blister carton label

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)

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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

Purpose

Acid reducer

Warnings

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

Directions

• adults and children 12 years and over:

• to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

10 mg:

• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn

20 mg:

• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating 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

Other Information (Other information)

• read the directions and warnings before use

• keep the carton. It contains important information.

• store at 20° to 25°C (68° to 77°F)

• protect from moisture

Inactive Ingredients (Inactive ingredients)


corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and film coating contains carnauba wax, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide; and additionally 20 mg contains iron oxide red and iron oxide yellow.

Questions Or Comments? (Questions or comments?)

1-866-495-1995

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Famotidine Tablets USP 10 mg - 30s container label

 







Famotidine Tablets USP 10 mg - 30s container carton label

   





Famotidine Tablets USP 10 mg - 10 (1x10) blister carton label

 







Famotidine Tablets USP 20 mg - 30s container label

 







Famotidine Tablets USP 20 mg - 30s container carton label









Famotidine Tablets USP 20 mg - 10 (1x10) blister carton label

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:20.280258 · Updated: 2026-03-14T23:00:43.590966