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

Purpose

Acid reducer

Description

Famotidine USP 10 mg and 20 mg


Medication Information

Warnings

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

Active Ingredient

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

Purpose

Acid reducer

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

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.

Description

Famotidine USP 10 mg and 20 mg

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  



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

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

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)

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

Warnings

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

Active Ingredient (Active ingredient (in each tablet))

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

Purpose

Acid reducer

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

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.

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  



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

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

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)

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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