FAMOTIDINE- famotidine tablet, film coated

famotidine by

Drug Labeling and Warnings

famotidine by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION, INC., Annora Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Famotidine USP 10 mg and 20 mg

Purpose

Acid reducer

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

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

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.

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  

INGREDIENTS AND APPEARANCE

FAMOTIDINE  
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-003-30	1 in 1 CARTON	03/06/2024
1		30 in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215766	03/06/2024

FAMOTIDINE  
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	yellow (Light yellow)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-008-50	1 in 1 CARTON	03/06/2024
1		50 in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215766	03/06/2024

Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Annora Pharma Private Limited		650980746	analysis(83324-003, 83324-008) , manufacture(83324-003, 83324-008)