Famotidine Tablets, USP 10 mg and 20 mg

Manufacturer
Graviti Pharmaceuticals Private Limited
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:51:57

Label at a glance#

ProductFamotidine
Active ingredientFAMOTIDINE
Label structure9 sections

Indications and 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

Dosage and administration

Directions for 10 mg 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 do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor Directions for 20 mg adults and children...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Original Strength

Drug Facts

Famotidine 10 mg

Maximum Strength

Drug Facts

Famotidine 20 mg

PURPOSE

OTC - PURPOSE SECTION

Acid reducer

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 are taking 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 breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get a medical help or contact a Poison Control Center right away. (1-800-222-1222)

DIRECTIONS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions for 10 mg

  • 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
  • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Directions for 20 mg

  • 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
  • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° - 25°C (68° - 77°F)
  • protect from moisture

FDA approved dissolution test specifications differ from USP.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc,

titanium dioxide.

For 10 mg: iron oxide black and iron oxide red,

For 20 mg: iron oxide yellow and iron oxide red.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll-free weekdays 9 AM to 5 PM EST at 1-855-298-4506

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 10 mg Tablet: Container Label

NDC 69844-097-01

Original Strength

*Compare to the active ingredient in Pepcid AC®

Famotidine Tablet, USP 10 mg

Acid Reducer

Just One Tablet!

Prevent & Relives Heartburn Due to Acid Indigestion

30 Tablets

Marketed by Graviti Pharmaceuticals Inc.

Made in India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 10 mg Tablet: Carton Label

NDC 69844-097-01

Original Strength

*Compare to the active ingredient in Pepcid AC®

Famotidine Tablet, USP 10 mg

Acid Reducer

Just One Tablet!

Prevent & Relives Heartburn Due to Acid Indigestion

30's Tablets Bottles pack

Marketed by Graviti Pharmaceuticals Inc.

Made in India.

10 mg 30's bottels pack
10 mg 30's bottels pack

Principal Display Panel - 10 mg Tablet: Carton Label

NDC 69844-097-04

Original Strength

*Compare to the active ingredient in Pepcid AC®

Famotidine Tablet, USP 10 mg

Acid Reducer

Just One Tablet!

Prevent & Relives Heartburn Due to Acid Indigestion

10's Blister Pack

Marketed by Graviti Pharmaceuticals Inc.

Made in India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 20 mg Tablets: Container Label

NDC 69844-098-01

Maximum Strength

*Compare to the active ingredient in Pepcid AC®

Famotidine Tablet, USP 20 mg

Acid Reducer

Just One Tablet!

Prevent & Relives Heartburn Due to Acid Indigestion

30 Tablets

Marketed by Graviti Pharmaceuticals Inc.

Made in India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 20 mg Tablets: Carton Label

NDC 69844-098-01

Maximum Strength

*Compare to the active ingredient in Pepcid AC®

Famotidine Tablet, USP 20 mg

Acid Reducer

Just One Tablet!

Prevent & Relives Heartburn Due to Acid Indigestion

30's Tablets Bottle Pack

Marketed by Graviti Pharmaceuticals Inc.

Made in India.

20 mg 30's bottel pack
20 mg 30's bottel pack

Principal Display Panel - 20 mg Tablets: Carton Label

NDC 69844-098-04

Maximum Strength

*Compare to the active ingredient in Pepcid AC®

Famotidine Tablet, USP 20 mg

Acid Reducer

Just One Tablet!

Prevent & Relives Heartburn Due to Acid Indigestion

10's Blister Pack

Marketed by Graviti Pharmaceuticals Inc.

Made in India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69844-09769844-097-01, 69844-097-02, 69844-097-04
69844-09869844-098-01, 69844-098-02, 69844-098-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
48ae9974-40b8-44ff-972b-087059cd04ab42c6b201-5eba-46ed-84d3-4c1ee2cae1242024-10-17WarningsExact identifier
spl id: 48ae9974-40b8-44ff-972b-087059cd04ab
spl set id: 42c6b201-5eba-46ed-84d3-4c1ee2cae124

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.