Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID ce584e98-5d52-4412-b18c-e623b4ae24d1
Route
ORAL
Published
Effective Date 2014-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Talc Starch, Corn Polyethylene Glycol 400 Cellulose, Microcrystalline Magnesium Stearate Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Pill Appearance
Imprint: W972 Shape: round Color: pink Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2014-03-14

Description

Active Ingredients Famotidine USP 10mg


Medication Information

Warnings and Precautions

Warnings: Allergy alert: Do not use if

you are allergic to famotidine or other acid reducers

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 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

Stop use and ask a doctor if • your

heartburn continues or worsens • you

need to take this product for more than

14 days

Indications and Usage

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

Dosage and Administration

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

Description

Active Ingredients Famotidine USP 10mg

Section 50565-1

 Keep

out of reach of children. In case of

overdose, get medical help or contact a Poison

Control Center right away.

Section 51727-6

Inactive ingredients hydroxypropyl

cellulose, hypromellose, iron oxide red, magnesium

stearate, microcrystalline cellulose, polyethylene

glycol 400, pregelatinized starch, talc, titanium

dioxide

Section 51945-4

MM1



Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1

Acid Reducer

Section 55106-9

Active Ingredients

Famotidine USP 10mg




Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings: Allergy alert: Do not use if

you are allergic to famotidine or other acid reducers

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 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

Stop use and ask a doctor if • your

heartburn continues or worsens • you

need to take this product for more than

14 days

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.

Section 51727-6 (51727-6)

Inactive ingredients hydroxypropyl

cellulose, hypromellose, iron oxide red, magnesium

stearate, microcrystalline cellulose, polyethylene

glycol 400, pregelatinized starch, talc, titanium

dioxide

Section 51945-4 (51945-4)

MM1



Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1 (55105-1)

Acid Reducer

Section 55106-9 (55106-9)

Active Ingredients

Famotidine USP 10mg




Advanced Ingredient Data


Raw Label Data

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