drug facts

drug facts
SPL v1
SPL
SPL Set ID c2af79bf-70e8-4de9-bea0-a2724f21064d
Route
oral
Published
Effective Date 2013-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
famotidine (10 mg)
Inactive Ingredients
colloidal silicon dioxide hydroxypropyl cellulose hypromelloses ferric oxide red magnesium stearate cellulose, microcrystalline polyethylene glycol 400 starch, pregelatinized corn talc titanium dioxide

Identifiers & Packaging

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

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, 10 mg Famotidine USP, 20 mg


Medication Information

Warnings

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

Active Ingredient

Famotidine USP, 10 mg

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
Purpose

Acid reducer

Directions

Famotidine USP, 10 mg

  • 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

Famotidine USP, 20 mg

  • 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
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 INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
  • 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, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

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, 10 mg Famotidine USP, 20 mg

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF ORIGINAL STRENGTH PEPCID ® AC

Best Choice ® Brand

ORIGINAL STRENGTH

ACID CONTROLLER

FAMOTIDINE TABLETS USP, 10 mg

ACID REDUCER

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

30 TABLETS

DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5085657/R0411

10 mg, 30's

COMPARE TO THE ACTIVE INGREDIENT OF ORIGINAL STRENGTH PEPCID ® AC

Best Choice ® Brand

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: VALU MERCHANDISERS, CO.

5078117/0310

20 mg, 25's
Questions?

Call 1-800-406-7984

Do Not Use

Famotidine USP, 10 mg

  • 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.

Famotidine USP, 20 mg

  • 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.
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).

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

Warnings (WARNINGS)

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

Active Ingredient (ACTIVE INGREDIENT (IN EACH TABLET))

Famotidine USP, 10 mg

Famotidine USP, 20 mg

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

Directions (DIRECTIONS)

Famotidine USP, 10 mg

  • 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

Famotidine USP, 20 mg

  • 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
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 INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.
Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENT OF ORIGINAL STRENGTH PEPCID ® AC

Best Choice ® Brand

ORIGINAL STRENGTH

ACID CONTROLLER

FAMOTIDINE TABLETS USP, 10 mg

ACID REDUCER

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

30 TABLETS

DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5085657/R0411

10 mg, 30's

COMPARE TO THE ACTIVE INGREDIENT OF ORIGINAL STRENGTH PEPCID ® AC

Best Choice ® Brand

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: VALU MERCHANDISERS, CO.

5078117/0310

20 mg, 25's
Questions? (QUESTIONS?)

Call 1-800-406-7984

Do Not Use (Do not use)

Famotidine USP, 10 mg

  • 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.

Famotidine USP, 20 mg

  • 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.
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).

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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