drug facts

drug facts

SPL v3

SPL

SPL Set ID 1e6cebc6-a79a-405e-9824-197534a8b08b

Route

oral

Published

Effective Date 2018-08-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

famotidine (10 mg)

Inactive Ingredients

silicon dioxide hydroxypropyl cellulose (1200000 mw) hypromellose, unspecified ferric oxide red magnesium stearate microcrystalline cellulose polyethylene glycol 400 starch, corn talc titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 036 Shape: round Color: pink Color: white Size: 8 mm Score: 1

Marketing Status

anda active Since 2010-07-23

Purpose

Acid reducer

Patient Information

1 tablet relieves heartburn due to acid indigestion Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. Tips for Managing Heartburn Do not lie flat or bend over after eating Do not wear tight-fitting clothing around the stomach Do not eat before bedtime Raise the head of your bed Avoid heartburn - causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables Eat slowly and avoid big meals If overweight, lose weight Quit smoking

Description

Famotidine USP, 10 mg Famotidine USP, 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

Famotidine USP, 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

Famotidine USP, 10 mg

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tablet with a glass of water 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

Famotidine USP, 20 mg

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- 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

store at 20° to 25°C (68° to 77°F)
protect from moisture
read the directions and warnings before use
keep the carton. It contains important information.
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

Inactive Ingredients

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Patient Information

1 tablet relieves heartburn due to acid indigestion
Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Tips for Managing Heartburn

Do not lie flat or bend over after eating
Do not wear tight-fitting clothing around the stomach
Do not eat before bedtime
Raise the head of your bed
Avoid heartburn - causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
Eat slowly and avoid big meals
If overweight, lose weight
Quit smoking

Description

Famotidine USP, 10 mg Famotidine USP, 20 mg

Questions?

Call 1-800-406-7984

Do Not Use

Famotidine USP, 10 mg

with other acid reducers
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.

Famotidine USP, 20 mg

with other acid reducers
if you have kidney disease, except under the advice and supervision of a doctor.
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.

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

frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
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

Principal Display Panel 20 Mg Tablet Bottle Carton

NDC 63868-486-25

QUALITY^®

CHOICE

^†Compare to

Active Ingredient in

Maximum Strength PEPCID AC^®

Maximum Strength

Acid

Controller

Famotidine Tablets, USP 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

25 Tablets

Principal Display Panel 10 Mg Tablet Blister Pack Carton

QUALITY^®

CHOICE

NDC 63868-714-30

^†Compare to

Active Ingredient in

Original Strength PEPCID AC^®

Original Strength

Acid

Controller

Famotidine Tablets, USP 10 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

30 Tablets

Structured Label Content

Warnings (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

Famotidine USP, 20 mg

Uses (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 (PURPOSE)

Acid reducer

Directions (DIRECTIONS)

Famotidine USP, 10 mg

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tablet with a glass of water 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

Famotidine USP, 20 mg

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- 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)

store at 20° to 25°C (68° to 77°F)
protect from moisture
read the directions and warnings before use
keep the carton. It contains important information.
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

Inactive Ingredients (INACTIVE INGREDIENTS)

Patient Information (PATIENT INFORMATION)

1 tablet relieves heartburn due to acid indigestion
Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Tips for Managing Heartburn

Do not lie flat or bend over after eating
Do not wear tight-fitting clothing around the stomach
Do not eat before bedtime
Raise the head of your bed
Avoid heartburn - causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
Eat slowly and avoid big meals
If overweight, lose weight
Quit smoking

Questions? (QUESTIONS?)

Call 1-800-406-7984

Do Not Use (Do not use)

Famotidine USP, 10 mg

with other acid reducers
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.

Famotidine USP, 20 mg

with other acid reducers
if you have kidney disease, except under the advice and supervision of a doctor.
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.

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)

frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
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

Principal Display Panel 20 Mg Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton)

NDC 63868-486-25

QUALITY^®

CHOICE

^†Compare to

Active Ingredient in

Maximum Strength PEPCID AC^®

Maximum Strength

Acid

Controller

Famotidine Tablets, USP 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

25 Tablets

Principal Display Panel 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton)

QUALITY^®

CHOICE

NDC 63868-714-30

^†Compare to

Active Ingredient in

Original Strength PEPCID AC^®

Original Strength

Acid

Controller

Famotidine Tablets, USP 10 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

30 Tablets

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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": "Famotidine USP, 10 mg adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 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 Famotidine USP, 20 mg adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. 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": "Famotidine USP, 10 mg with other acid reducers 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. Famotidine USP, 20 mg with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor. 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.", "QUESTIONS?": "Call 1-800-406-7984", "OTHER INFORMATION": "store at 20° to 25°C (68° to 77°F) protect from moisture read the directions and warnings before use keep the carton. It contains important information. TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.", "PATIENT INFORMATION": "1 tablet relieves heartburn due to acid indigestion Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. Tips for Managing Heartburn Do not lie flat or bend over after eating Do not wear tight-fitting clothing around the stomach Do not eat before bedtime Raise the head of your bed Avoid heartburn - causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables Eat slowly and avoid big meals If overweight, lose weight Quit smoking", "INACTIVE INGREDIENTS": "Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide", "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 Famotidine USP, 20 mg", "Ask a doctor before use if you have": "frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain 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", "PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton": "NDC 63868-486-25 QUALITY ® CHOICE † Compare to Active Ingredient in Maximum Strength PEPCID AC ® Maximum Strength Acid Controller Famotidine Tablets, USP 20 mg Acid Reducer Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion 25 Tablets", "PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton": "QUALITY ® CHOICE NDC 63868-714-30 † Compare to Active Ingredient in Original Strength PEPCID AC ® Original Strength Acid Controller Famotidine Tablets, USP 10 mg Acid Reducer Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion 30 Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:37.695892 · Updated: 2026-03-14T22:55:14.803903