OTC Medication Information: Acid Reducer Maximum Strength

ACID REDUCER MAXIMUM STRENGTH- famotidine tablet
Allegiant Health

Active ingredient(s)

Famotidine USP 20mg

Purpose

Acid reducer

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

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

  • 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 are taking 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

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)

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 15 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

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

Inactive ingredients

Hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline
cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

Questions/Comments

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

Principal Display Panel

Famotidine Tablets, USP 20mg
(click image for full-size original)

Famotidine Tablets, USP 20mg

ACID REDUCER MAXIMUM STRENGTH
famotodine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-443
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code V;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69168-443-32 100 TABLET in 1 BOTTLE None
2 NDC:69168-443-52 225 TABLET in 1 BOTTLE None
3 NDC:69168-443-09 10 TABLET in 1 BLISTER PACK None
4 NDC:69168-443-50 1 BOTTLE in 1 CARTON contains a BOTTLE
4 50 TABLET in 1 BOTTLE This package is contained within the CARTON (69168-443-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215822 01/15/2024
Labeler — Allegiant Health (079501930)

Revised: 01/2024 Allegiant Health

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.