Principal Display Panel

Principal Display Panel
SPL v6
SPL
SPL Set ID 653c165e-3e22-4796-b170-cc87547574c4
Route
ORAL
Published
Effective Date 2017-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Famotidine, USP 20 mg


Medication Information

Warnings and Precautions

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

Indications and Usage

• 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

• 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

Description

Famotidine, USP 20 mg

Section 42229-5

• 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. (for blister carton) • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for bottle carton/label) • TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for SAL/extended label)

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

• your heartburn continues or worsens • you need to take this product for more than 14 days

Section 50569-3

• 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

Section 50570-1

• 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.

Section 51727-6

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Section 51945-4

† Compare to the active ingredient of Maximum Strength Pepcid AC ® . NDC 51660-036-26 ohm ® MAXIMUM STRENGTH Acid Controller Famotidine Tablets, USP 20 mg Acid Reducer Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion 25 TABLETS Distributed by: Ohm Laboratories Inc. 5142565/R0517 25's Blister Carton

Section 53413-1

call 1-800-406-7984

Section 53414-9

ask a health professional before use.

Section 55105-1

Acid reducer

Section 55106-9

Famotidine, USP 20 mg


Structured Label Content

Indications and Usage (34067-9)

• 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)

• 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

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

• 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. (for blister carton) • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for bottle carton/label) • TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for SAL/extended label)

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

• your heartburn continues or worsens • you need to take this product for more than 14 days

Section 50569-3 (50569-3)

• 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

Section 50570-1 (50570-1)

• 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.

Section 51727-6 (51727-6)

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Section 51945-4 (51945-4)

† Compare to the active ingredient of Maximum Strength Pepcid AC ® . NDC 51660-036-26 ohm ® MAXIMUM STRENGTH Acid Controller Famotidine Tablets, USP 20 mg Acid Reducer Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion 25 TABLETS Distributed by: Ohm Laboratories Inc. 5142565/R0517 25's Blister Carton

Section 53413-1 (53413-1)

call 1-800-406-7984

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Acid reducer

Section 55106-9 (55106-9)

Famotidine, USP 20 mg


Raw Label Data

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