Famotidine Tablets Usp, 20 Mg - Cool Mint Flavor

Famotidine Tablets Usp, 20 Mg - Cool Mint Flavor
SPL v2
SPL
SPL Set ID 5a66206b-35b1-4d86-8574-a1e45cb0772f
Route
ORAL
Published
Effective Date 2025-05-23
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Silicon Dioxide Carnauba Wax Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose 102 Starch, Corn Saccharin Sodium Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 124 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2025-05-23

Description

Active ingredient (in each tablet) Famotidine USP 20 mg

Purpose

Purpose  Acid reducer


Medication Information

Purpose

Purpose 

Acid reducer

Description

Active ingredient (in each tablet) Famotidine USP 20 mg

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

Warnings

Warnings



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

Directions

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

- 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

•keep the carton. It contains important information.

•store at 20°-25°C (68°-77°F)

•protect from moisture

•Meets USP dissolution test 2

Active Ingredient(s)

Active ingredient (in each tablet)

Famotidine USP 20 mg

Inactive Ingredients

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

Questions Or Comments

Questions or comments? Call 1-877-376-4271 (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 

Pregnancy/breastfeeding

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

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







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

•frequent chest pain

•frequent wheezing, particularly with heartburn

•unexplained weight loss

•nausea or vomiting

•stomach pain

•kidney disease  

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

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.


Structured Label Content

Use(s) (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

Purpose (PURPOSE)

Purpose 

Acid reducer

Warnings (WARNINGS)

Warnings



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

Directions (DIRECTIONS)

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

- do not use more than 2 tablets in 24 hours

•children under 12 years: ask a doctor



Do Not Use (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)

Other 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

•Meets USP dissolution test 2

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Active ingredient (in each tablet)

Famotidine USP 20 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments (QUESTIONS OR COMMENTS)

Questions or comments? Call 1-877-376-4271 (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 

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

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

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







Ask A Doctor Before Use If (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

•frequent chest pain

•frequent wheezing, particularly with heartburn

•unexplained weight loss

•nausea or vomiting

•stomach pain

•kidney disease  

Stop Use and Ask Doctor If (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

Keep Out of Reach of Children (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)

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)