Famotidine Tablets Usp, 10 Mg And 20 Mg

Famotidine Tablets Usp, 10 Mg And 20 Mg
SPL v5
SPL
SPL Set ID 58b653eb-6539-4b79-9d22-df6eaf35307f
Route
ORAL
Published
Effective Date 2024-09-30
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose 102 Starch, Corn Ferric Oxide Red Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 87 Shape: square Shape: semi-circle Color: pink Color: white Size: 7 mm Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2023-03-10

Description

For 10 mg: Famotidine USP 10 mg For 20 mg: Famotidine USP 20 mg

Purpose

Acid Reducer


Medication Information

Purpose

Acid Reducer

Description

For 10 mg: Famotidine USP 10 mg For 20 mg: Famotidine USP 20 mg

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

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

Directions

For 10 mg:

• adults and children 12 years and over:

o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

o 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

o do not use more than 2 tablets in 24 hours

• children under 12 years: ask a doctor



For 20 mg:

• adults and children 12 years and over:

o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

o 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

o do not use more than 2 tablets in 24 hours

• children under 12 years: ask a doctor

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

• 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





Inactive Ingredients

For 10 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide



For 20 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

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 

Principal Display Panel

Famotidine Tablets USP, 10 mg



NDC: 25000-086-36

Famotidine Tablets USP 10 mg

30's (3 x 10's blister) count Carton Label

 



NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Bottle Label

 



NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Carton Label

 



NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Bottle Label

 



NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Carton Label

 



Famotidine Tablets USP, 20 mg



NDC: 25000-087-36

Famotidine Tablets USP 20 mg

30's (3 x 10's blister) count Carton Label





NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Bottle Label

 



NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Carton Label

 



NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Bottle Label

 



NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Carton Label

 



NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Carton Label

 



NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Bottle Label

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 medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active Ingredient (in Each Tablet)

For 10 mg:

Famotidine USP 10 mg



For 20 mg:

Famotidine USP 20 mg

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 a prescription drug. Acid reducers may interact with certain prescription drugs.  


Structured Label Content

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

Acid Reducer

Warnings

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

Directions

For 10 mg:

• adults and children 12 years and over:

o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

o 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

o do not use more than 2 tablets in 24 hours

• children under 12 years: ask a doctor



For 20 mg:

• adults and children 12 years and over:

o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

o 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

o 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





Inactive Ingredients (Inactive ingredients)

For 10 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide



For 20 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, 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 

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Famotidine Tablets USP, 10 mg



NDC: 25000-086-36

Famotidine Tablets USP 10 mg

30's (3 x 10's blister) count Carton Label

 



NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Bottle Label

 



NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Carton Label

 



NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Bottle Label

 



NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Carton Label

 



Famotidine Tablets USP, 20 mg



NDC: 25000-087-36

Famotidine Tablets USP 20 mg

30's (3 x 10's blister) count Carton Label





NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Bottle Label

 



NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Carton Label

 



NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Bottle Label

 



NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Carton Label

 



NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Carton Label

 



NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Bottle Label

Stop Use and Ask A 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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.



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)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

For 10 mg:

Famotidine USP 10 mg



For 20 mg:

Famotidine USP 20 mg

Ask A Doctor Before Use If You Have (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 (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

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