Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 4c077059-3074-4cd9-88e8-aef26af82953
Route
ORAL
Published
Effective Date 2018-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Silicon Dioxide Hydroxypropyl Cellulose (1200000 Mw) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 036 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2014-04-09

Description

Famotidine, USP 20 mg

Purpose

Acid reducer

Patient Information

• JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. 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
  • JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

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 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?

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.
Inactive Ingredients

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, 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
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
Principal Display Panel 20 Mg Tablet Bottle Carton

Compare to Maximum Strength Pepcid AC®

active ingredient

NDC 37808-036-50

H-E-B ®

Maximum Strength

Acid Controller

Famotidine Tablets, USP 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

actual size

50 TABLETS


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 (Do not use)
  • 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? (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.
Patient Information (PATIENT INFORMATION)
  • JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

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

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
Principal Display Panel 20 Mg Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton)

Compare to Maximum Strength Pepcid AC®

active ingredient

NDC 37808-036-50

H-E-B ®

Maximum Strength

Acid Controller

Famotidine Tablets, USP 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

actual size

50 TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)