Famotidine Tablets

Famotidine Tablets
SPL v4
SPL
SPL Set ID 95f51f27-d367-4cfd-a15f-7856c9e361fb
Route
ORAL
Published
Effective Date 2026-01-13
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 (110000 Wamw) Magnesium Stearate Hypromellose 2910 (6 Mpa.s) Titanium Dioxide Triacetin Polyethylene Glycol 4000 Talc

Identifiers & Packaging

Pill Appearance
Imprint: V;15 Shape: round Color: white Size: 5 mm Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-10-08

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:
    • o
      to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • o
      to prevent symptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn

    • o
      to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn

    • o
      before eating food or drinking beverages that cause heartburn
    • o
      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
Allergy Alert

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

Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°C to 25°C (68°F to 77°F)
  • protect from moisture
Inactive Ingredients

Hydroxypropyl Cellulose, Hypromellose, , Macrogol, Magnesium stearate, Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Talc, Triacetin, Titanium dioxide

Questions Or Comments?

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Do not use if printed foil seal on bottle is broken or missing.

JUST ONE TABLET prevents and relieves 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

NDC 72657-112-90

Famotidine Tablets, USP 10mg

90 Tablets

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 10 mg and 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

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:
    • o
      to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • o
      to prevent symptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn

    • o
      to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn

    • o
      before eating food or drinking beverages that cause heartburn
    • o
      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
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
  • keep the carton. It contains important information.
  • store at 20°C to 25°C (68°F to 77°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

Hydroxypropyl Cellulose, Hypromellose, , Macrogol, Magnesium stearate, Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Talc, Triacetin, Titanium dioxide

Questions Or Comments? (Questions or comments?)

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Do not use if printed foil seal on bottle is broken or missing.

JUST ONE TABLET prevents and relieves 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

NDC 72657-112-90

Famotidine Tablets, USP 10mg

90 Tablets

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 10 mg and 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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)