Welmate Famotidine 10mg 73581-108-10

Welmate Famotidine 10mg 73581-108-10
SPL v2
SPL
SPL Set ID 1e19d0cc-65d7-8ec4-e063-6394a90a3d2a
Route
ORAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 5 mm Score: 1
Marketing Status
ANDA Active Since 2024-07-25

Description

Famotidine, USP 10 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Famotidine, USP 10 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
Warnings

Allergy alert

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

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

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



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

Stop use and ask a doctor if

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



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 (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
  • 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
  • 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
  • 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

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch Glycolate, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc, Macrogol

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)

Active Ingredient (in Each Tablet)

Famotidine, USP 10 mg

Package Label.principal Display Panel 90's Count

Package Label.principal Display Panel 300's Count


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
Purpose

Acid reducer

Warnings

Allergy alert

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

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

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



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

Stop use and ask a doctor if

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



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 (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
  • 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
  • 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)
  • 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

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch Glycolate, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc, Macrogol

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)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Famotidine, USP 10 mg

Package Label.principal Display Panel 90's Count (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-90's Count)

Package Label.principal Display Panel 300's Count (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-300's Count)


Advanced Ingredient Data


Raw Label Data

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