Famotidine 20 mg
Famotidine Tablets USP, 20 mg - Cool Mint Flavor
5a66206b-35b1-4d86-8574-a1e45cb0772f
HUMAN OTC DRUG LABEL
May 6, 2025
MARKSANS PHARMA LIMITED
DUNS: 925822975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Famotidine 20 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC: 25000-124-94
Famotidine Tablets USP 20 mg- Cool mint flavor
25's (5 x 5's blister) count Carton Label

NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Bottle Label

NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Carton Label
NDC: 25000-124-68
Famotidine Tablets USP 20 mg- Cool mint flavor
300's count Bottle Label

INDICATIONS & USAGE SECTION
USE(S)
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
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT(S)
Active ingredient (in each tablet)
Famotidine USP 20 mg
OTC - PURPOSE SECTION
PURPOSE
Purpose
Acid reducer
WARNINGS SECTION
WARNINGS
Warnings****
** Allergy alert:**Do not use if you are allergic to famotidine or other acid reducers
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
ASK A DOCTOR BEFORE USE IF
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
•frequentchest pain
•frequent wheezing, particularly with heartburn
•unexplained weight loss
•nausea or vomiting
•stomach pain
•kidney disease
OTC - ASK DOCTOR/PHARMACIST SECTION
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.
OTC - STOP USE SECTION
STOP USE AND ASK 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
PREGNANCY/BREASTFEEDING
**If pregnant or breast-feeding,**ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS
Directions
•adults and children 12 years and over:
- torelieve symptoms, swallow 1 tablet with a glass of water. Do not
chew.
- toprevent symptoms, swallow 1 tablet with a glass of water at any time
from10 to 60 minutes 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
SPL UNCLASSIFIED SECTION
QUESTIONS OR COMMENTS
Questions or comments? Call1-877-376-4271(weekdays 9 AM to 5 PM)
•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
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS
Inactive ingredients carnauba wax, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium saccharin, talc, titanium dioxide