443 - Acid Reducer

443 - Acid Reducer
SPL v5
SPL
SPL Set ID adc2721d-2ca7-4a47-bae1-be298fa1c155
Route
ORAL
Published
Effective Date 2024-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Polyethylene Glycol, Unspecified Magnesium Stearate Microcrystalline Cellulose Starch, Corn Sodium Starch Glycolate Type A Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: V;15 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-01-15
Description

Famotidine USP 20mg

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

Famotidine USP 20mg

Use(s)
  • 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

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 n 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
Other Information
  • read the directions and warnings before use
  • do not use if imprinted safety seal under cap is broken or missing
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM − 5PM EST

Active Ingredient(s)

Famotidine USP 20mg

Inactive Ingredients

Hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline

cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

Principal Display Panel
Acid Reducer
Ask A Doctor Before Use If
  • 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
Stop Use and Ask A Doctor If
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
If Pregnant Or Breastfeeding,

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)

Ask A Doctor Or Pharmacist Before Use If

you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Structured Label Content

Use(s)
  • 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

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 n 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
Other Information (Other information)
  • read the directions and warnings before use
  • do not use if imprinted safety seal under cap is broken or missing
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM − 5PM EST

Active Ingredient(s) (Active ingredient(s))

Famotidine USP 20mg

Inactive Ingredients (Inactive ingredients)

Hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline

cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

Principal Display Panel
Acid Reducer
Ask A Doctor Before Use If (Ask a doctor before use if)
  • 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
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
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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)

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:06.637505 · Updated: 2026-03-14T23:13:03.799451