Famotidine - Acid Controller

SPL v3

SPL

SPL Set ID d622b654-bd85-4da9-aeaa-3c6a362e5b0b

Route

ORAL

Published

Effective Date 2018-09-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 2012-05-01

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 53414-9

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

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?

or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

Allergy Alert

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

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.

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

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 10 Mg Blister Pack Carton

*Compare to the active ingredient in PEPCID AC^® Original Strength

WinCo™

FOODS

ORIGINAL STRENGTH

Acid Controller

FAMOTIDINE TABLETS,

USP 10 mg/

ACID REDUCER

JUST ONE TABLET Prevents & Relieves Heartburn

Due to Acid Indigestion

30

Tablets

Principal Display Panel 20 Mg Blister Pack Carton

*Compare to the active ingredient in PEPCID AC^® Maximum Strength

WinCo™

FOODS

MAXIMUM STRENGTH

Acid Controller

FAMOTIDINE TABLETS,

USP 20 mg/

ACID REDUCER

JUST ONE TABLET Prevents & Relieves Heartburn

Due to Acid Indigestion

25

Tablets

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 53414-9 (53414-9)

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

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

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.

Questions?

or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

Allergy Alert (Allergy alert)

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

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.

Inactive Ingredients (Inactive ingredients)

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

Famotidine, USP 20 mg

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 10 Mg Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Carton)

*Compare to the active ingredient in PEPCID AC^® Original Strength

WinCo™

FOODS

ORIGINAL STRENGTH

Acid Controller

FAMOTIDINE TABLETS,

USP 10 mg/

ACID REDUCER

JUST ONE TABLET Prevents & Relieves Heartburn

Due to Acid Indigestion

30

Tablets

Principal Display Panel 20 Mg Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton)

*Compare to the active ingredient in PEPCID AC^® Maximum Strength

WinCo™

FOODS

MAXIMUM STRENGTH

Acid Controller

FAMOTIDINE TABLETS,

USP 20 mg/

ACID REDUCER

JUST ONE TABLET Prevents & Relieves Heartburn

Due to Acid Indigestion

25

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", "42229-5": "Drug Facts", "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).", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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", "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?": "or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST", "Allergy alert": "Do not use if you are allergic to famotidine or other acid reducers", "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.", "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", "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 - 10 mg Blister Pack Carton": "*Compare to the active ingredient in PEPCID AC ® Original Strength WinCo™ FOODS ORIGINAL STRENGTH Acid Controller FAMOTIDINE TABLETS, USP 10 mg/ ACID REDUCER JUST ONE TABLET Prevents & Relieves Heartburn Due to Acid Indigestion 30 Tablets", "PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton": "*Compare to the active ingredient in PEPCID AC ® Maximum Strength WinCo™ FOODS MAXIMUM STRENGTH Acid Controller FAMOTIDINE TABLETS, USP 20 mg/ ACID REDUCER JUST ONE TABLET Prevents & Relieves Heartburn Due to Acid Indigestion 25 Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:38.681797 · Updated: 2026-03-14T22:55:14.803903