SPL v1
SPL
SPL Set ID 9974aa5e-e03f-4459-934a-ece27a830746
Route
ORAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Microcrystalline Cellulose Starch, Corn Sodium Starch Glycolate Type A Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Hypromellose, Unspecified Titanium Dioxide Triacetin Polyethylene Glycol, Unspecified Talc

Identifiers & Packaging

Pill Appearance
Imprint: V;21 Shape: round Color: white Size: 5 mm Score: 1
Marketing Status
ANDA Active Since 2025-04-01

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 (1-800-222-1222) right away. 

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking 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 relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating 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.
Questions?

call toll-free 1-844-912-4012

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° - 25°C (68° - 77°F)
  • protect from moisture
Inactive Ingredients

Hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, polyethylene glycol, talc, titanium dioxide, triacetin.

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 10 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 wheezing, particularly with heartburn
  • frequent chest pain
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease
Package Label Principal Display Panel


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 (1-800-222-1222) right away. 

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking 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 relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating 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 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 toll-free 1-844-912-4012

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° - 25°C (68° - 77°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

Hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, polyethylene glycol, talc, titanium dioxide, triacetin.

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 10 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 wheezing, particularly with heartburn
  • frequent chest pain
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease
Package Label Principal Display Panel (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)