Famotidine

Famotidine
SPL v3
SPL
SPL Set ID 1a43eb84-da0b-4c06-ba0d-e4a469ecaa6a
Route
ORAL
Published
Effective Date 2019-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Silicon Dioxide Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 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 2013-05-01

Description

Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

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 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9

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

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
  • 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
Questions?

Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

Allergy Alert

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

Other Information
  • read the directions and warnings before use
  • store at 20° to 25° C (68° to 77° F)
  • protect from moisture
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
Active Ingredient (in Each Tablet)

Famotidine, USP 20 mg

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
Principal Display Panel 20 Mg Tablet Bottle Label

NDC 46122-168-78

GOOD

NEIGHBOR

PHARMACY®

Compare to the active ingredient of

Maximum Strength Pepcid AC®

famotidine tablets, USP 20 mg

Acid Reducer

Maximum Strength

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

100 tablets


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9 (53414-9)

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

Purpose

Acid reducer

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)
  • 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
Questions?

Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

Allergy Alert (Allergy alert)

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

Other Information (Other information)
  • read the directions and warnings before use
  • store at 20° to 25° C (68° to 77° F)
  • protect from moisture
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
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)
  • 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
Principal Display Panel 20 Mg Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label)

NDC 46122-168-78

GOOD

NEIGHBOR

PHARMACY®

Compare to the active ingredient of

Maximum Strength Pepcid AC®

famotidine tablets, USP 20 mg

Acid Reducer

Maximum Strength

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

100 tablets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)