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

Purpose

Acid reducer

Description

Famotidine USP 10 mg and 20 mg


Medication Information

Warnings

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

Active Ingredient

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

Purpose

Acid reducer

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

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.

Description

Famotidine USP 10 mg and 20 mg

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

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

Questions Or Comments?

1-866-495-1995

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)

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

Warnings

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

Active Ingredient (Active ingredient (in each tablet))

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

Purpose

Acid reducer

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

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.

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

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

Questions Or Comments? (Questions or comments?)

1-866-495-1995

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)

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

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