Famotidine Tablets USP, 10 mg

Famotidine Tablets USP, 10 mg

Drug Labeling and Warnings

Drug Details

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FAMOTIDINE- famotidine tablet 
Wockhardt USA LLC.

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Famotidine Tablets USP, 10 mg

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 10 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.    

●   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 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 25°-30°C (77°-86°F)

●  protect from moisture

●  keep the carton and package insert. They contain important information.

INACTIVE INGREDIENT

hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, 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.100510

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP, 10 mg (OTC)

10 mg – Acid reducer

64679-972-03

Label
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64679-972
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINK (pink) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code W;972
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64679-972-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2005
2NDC: 64679-972-0210 in 1 CARTON03/07/2005
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 64679-972-0050000 in 1 DRUM; Type 0: Not a Combination Product03/07/2005
4NDC: 64679-972-0340000 in 1 DRUM; Type 0: Not a Combination Product03/07/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07714603/07/2005
Labeler - Wockhardt USA LLC. (170508365)
Registrant - Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited916489953ANALYSIS(64679-972) , LABEL(64679-972) , MANUFACTURE(64679-972) , PACK(64679-972)

Revised: 12/2018
 
Wockhardt USA LLC.


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