Famotidine Tablets USP, 20 mg

Famotidine Tablets USP, 20 mg

Drug Labeling and Warnings

Drug Details

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FAMOTIDINE- famotidine tablet 
Wockhardt USA LLC.

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Famotidine Tablets USP, 20 mg

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 20 mg

OTC - PURPOSE SECTION

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.

●  if you have kidney disease, except under the advice and supervision of a 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

Stop use and ask a doctor if

●  your heartburn continues or worsens

●  you need to take this product for more than 14 days

PREGNANCY OR BREAST FEEDING

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

 

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

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

OTHER INFORMATION

●  read the directions and warnings before use

●  store at 20°-25°C (68°-77°F)

●  keep the carton. It contains important information.

●  protect from moisture

INACTIVE INGREDIENT

Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

QUESTIONS OR COMMENTS

Call 1-800-346-6854

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.130810

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP, 20 mg (OTC)

20 mg – Acid reducer

64679-374-05

Label-20 mg
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64679-374
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (white) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code W374
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64679-374-011 in 1 CARTON08/06/2010
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 64679-374-081 in 1 CARTON08/06/2010
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 64679-374-051 in 1 CARTON08/06/2010
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 64679-374-0710 in 1 CARTON08/06/2010
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC: 64679-374-0038000 in 1 DRUM; Type 0: Not a Combination Product08/06/2010
6NDC: 64679-374-096500 in 1 DRUM; Type 0: Not a Combination Product08/06/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09083708/06/2010
Labeler - Wockhardt USA LLC. (170508365)
Registrant - Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited916489953ANALYSIS(64679-374) , LABEL(64679-374) , MANUFACTURE(64679-374) , PACK(64679-374)

Revised: 12/2018
 
Wockhardt USA LLC.


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