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Famotidine 20 mg

Famotidine Tablets USP, 20 mg - Cool Mint Flavor

Approved
Approval ID

5a66206b-35b1-4d86-8574-a1e45cb0772f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 6, 2025

Manufacturers
FDA

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
NDC Product Code25000-124
Application NumberANDA217543
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine 20 mg
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2025
FDA Product Classification

INGREDIENTS (11)

FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

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

![famotidine-20mg-5x5s-cool-mint-blister- ifc](/dailymed/image.cfm?name=famotidine-20mg-5x5s-cool-mint-blister- ifc.jpg&id=876678)

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

![famotidine-20mg-25s-cool-mint- label](/dailymed/image.cfm?name=famotidine-20mg-25s-cool-mint- label.jpg&id=876678)

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

famotidine-20mg-25s-cool-mint- ifc

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

![famotidine-20mg-300s-cool-mint- label](/dailymed/image.cfm?name=famotidine-20mg-300s-cool-mint- label.jpg&id=876678)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

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

LOINC: 55106-9Updated: 5/23/2025

ACTIVE INGREDIENT(S)

Active ingredient (in each tablet)
Famotidine USP 20 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

PURPOSE

Purpose
Acid reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

WARNINGS

Warnings****


** Allergy alert:**Do not use if you are allergic to famotidine or other acid reducers

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

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

LOINC: 50569-3Updated: 5/23/2025

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

LOINC: 50568-5Updated: 5/23/2025

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

LOINC: 50566-9Updated: 5/23/2025

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

LOINC: 53414-9Updated: 5/23/2025

PREGNANCY/BREASTFEEDING

**If pregnant or breast-feeding,**ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/23/2025

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

LOINC: 34068-7Updated: 5/23/2025

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

LOINC: 42229-5Updated: 5/23/2025

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

LOINC: 51727-6Updated: 5/23/2025

INACTIVE INGREDIENTS

Inactive ingredients carnauba wax, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium saccharin, talc, titanium dioxide

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Famotidine 20 mg - FDA Drug Approval Details