FDA.report

Drug Facts

Set ID
2a9153f1-3778-4f6f-b9b0-4c0bcaf49060
Manufacturer
Select Brand | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2013-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:11

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT (IN EACH TABLET)

Famotidine USP, 10 mg

PURPOSE

Acid reducer

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

Warnings

WARNINGS

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

Directions And Dosage

DIRECTIONS

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

Other Label Information

INACTIVE INGREDIENTS

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-370-12 Original Strength Acid Controller Famotidine Tablets USP, 10 mg Acid Reducer † Compare to the active ingredient of Original Strength Pepcid AC ® Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion 12 Tablets Distributed by: SELECT BRAND ® DISTRIBUTORS 5102118/R0413

NDC Codes

Ingredients

NameUNIIKind
FAMOTIDINE5QZO15J2Z8ACTIB
COLLOIDAL SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
HYPROMELLOSES3NXW29V3WOIACT
FERRIC OXIDE RED1K09F3G675IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Complete SPL Sections

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP, 10 mg

PURPOSE

OTC - PURPOSE SECTION

Acid reducer

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PATIENT INFORMATION

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-370-12 Original Strength Acid Controller Famotidine Tablets USP, 10 mg Acid Reducer † Compare to the active ingredient of Original Strength Pepcid AC ® Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion 12 Tablets Distributed by: SELECT BRAND ® DISTRIBUTORS 5102118/R0413

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc14f9b3e4-d31d-4e20-a402-a2c84d11a3f1.xml2013-07-18
otcFamo10.jpg2013-07-18