Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f7a7a24b-ecd9-4dab-9d1e-0b03aa99c08e
Route
ORAL
Published
Effective Date 2013-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Colloidal Silicon Dioxide Hydroxypropyl Cellulose Hypromelloses Polyethylene Glycol 400 Magnesium Stearate Cellulose, Microcrystalline Starch, Pregelatinized Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 036 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2010-07-23

Description

Famotidine USP, 20 mg

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


Medication Information

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, 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
Warnings

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

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 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
  • 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.
  • if you have kidney disease, except under the advice and supervision of a 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 PRINTED FOIL UNDER CAP IS OPEN OR TORN.
Inactive Ingredients

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

Principal Display Panel

SHOPKO ®

Compare to the Active Ingredient of 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

Manufactured by: Ohm Laboratories Inc.

5091040/0212

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, 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

Structured Label Content

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

Warnings (WARNINGS)

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

Directions (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 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
  • 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.
  • if you have kidney disease, except under the advice and supervision of a doctor.
Questions? (QUESTIONS?)

Call 1-800-406-7984

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 PRINTED FOIL UNDER CAP IS OPEN OR TORN.
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
Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SHOPKO ®

Compare to the Active Ingredient of 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

Manufactured by: Ohm Laboratories Inc.

5091040/0212

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).

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

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

Advanced Ingredient Data


Raw Label Data

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