Famotidine Tablets Usp, 10 Mg And 20 Mg

Famotidine Tablets Usp, 10 Mg And 20 Mg
SPL v1
SPL
SPL Set ID 6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6
Route
ORAL
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Magnesium Stearate Hypromellose 2910 (15 Mpa.s) Microcrystalline Cellulose 101 Starch, Corn Sodium Starch Glycolate Type A Potato Hypromellose 2910 (5 Mpa.s) Microcrystalline Cellulose 102 Hydroxypropyl Cellulose, Unspecified Titanium Dioxide Talc Carnauba Wax Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: T;11 Shape: round Color: white Color: yellow Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-03-06

Description

Famotidine USP 10 mg and 20 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Famotidine USP 10 mg and 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

• adults and children 12 years and over:

• to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.

10 mg:

• to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn

20 mg:

• to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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


• 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° to 25°C (68° to 77°F)

• protect from moisture

Inactive Ingredients


10 mg:

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide.

20 mg:

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, red iron oxide and yellow iron oxide.

Questions Or Comments?


1-888-375-3784

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







Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Principal Display Panel


Famotidine Tablets USP 10 mg - 30s container label

   







Famotidine Tablets USP 10 mg - 30s container carton label

   



Famotidine Tablets USP 20 mg - 50s container label

  



Famotidine Tablets USP 20 mg - 50s container carton 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)

Famotidine USP 10 mg and 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

• adults and children 12 years and over:

• to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.

10 mg:

• to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn

20 mg:

• to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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° to 25°C (68° to 77°F)

• protect from moisture

Inactive Ingredients (Inactive ingredients)


10 mg:

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide.

20 mg:

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, red iron oxide and yellow iron oxide.

Questions Or Comments? (Questions or comments?)


1-888-375-3784

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







Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Famotidine Tablets USP 10 mg - 30s container label

   







Famotidine Tablets USP 10 mg - 30s container carton label

   



Famotidine Tablets USP 20 mg - 50s container label

  



Famotidine Tablets USP 20 mg - 50s container carton 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))

Famotidine USP 10 mg and 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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