Famotidine Tablets Usp, 20mg

Famotidine Tablets Usp, 20mg
SPL v4
SPL
SPL Set ID fe25e1e2-7158-6fe0-e053-6394a90a3bb1
Route
ORAL
Published
Effective Date 2023-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Titanium Dioxide Carnauba Wax Silicon Dioxide Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Talc Magnesium Stearate Microcrystalline Cellulose Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: 87 Shape: semi-circle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2023-06-15

Description

Active ingredient (in each tablet) Famotidine USP 20 mg


Medication Information

Warnings and Precautions

Warnings

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

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 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

Active ingredient (in each tablet) Famotidine USP 20 mg

Section 50565-1

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).

Section 50566-9

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Section 50569-3

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
  • kidney disease
Section 50570-1

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
Section 51727-6

Inactive ingredients carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Acid reducer

Section 55106-9

Active ingredient (in each tablet)

Famotidine USP 20 mg

Section 60561-8

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
  • FDA approved dissolution test specifications differ from USP

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 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)

Warnings

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

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 (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Section 50569-3 (50569-3)

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
  • kidney disease
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Acid reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Famotidine USP 20 mg

Section 60561-8 (60561-8)

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
  • FDA approved dissolution test specifications differ from USP

Advanced Ingredient Data


Raw Label Data

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