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Famotidine by Aurohealth LLC

Dosage form: tablet, film coated
Ingredients: FAMOTIDINE 10mg
Labeler: Aurohealth LLC
NDC Code: 58602-705


Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 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 

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 (1-800-222-1222) 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 15 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
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture

Inactive ingredients


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

Questions or comments?

call 1-855-274-4122


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

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code: TS/DRUGS/22/2009


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets, Container Label)

AUROHEALTH

NDC 58602-705-19
ORIGINAL STRENGTH
Famotidine
Tablets USP 10 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

90 Tablets



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (90 Tablets, Container Carton Label)

AUROHEALTH

NDC 58602-705-19
*Compare to the Active Ingredient
of Original Strength Pepcid® AC
ORIGINAL STRENGTH
Famotidine
Tablets USP
10 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

90 Tablets




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg, Blister Carton 30 Tablets

AUROHEALTH

NDC 58602-705-09
*Compare to the Active
Ingredient of Original
Strength Pepcid® AC
ORIGINAL STRENGTH
Famotidine
Tablets USP
10 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

30 Tablets





FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-705
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSE 2910 (5 MPA.S) 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
FERRIC OXIDE RED 
SODIUM STARCH GLYCOLATE TYPE A CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeROUND (biconvex) Size5mm
FlavorImprint CodeCC;58
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-705-151 BOTTLE in 1 CARTON
160 TABLET, FILM COATED in 1 BOTTLE
2NDC:58602-705-191 BOTTLE in 1 CARTON
290 TABLET, FILM COATED in 1 BOTTLE
3NDC:58602-705-093 BLISTER PACK in 1 CARTON
3NDC:58602-705-0310 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:58602-705-124 BLISTER PACK in 1 CARTON
4NDC:58602-705-0310 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:58602-705-9390 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653104/26/2016
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(58602-705), MANUFACTURE(58602-705)

 
Aurohealth LLC

← See all Famotidine brands

Medically reviewed on Sep 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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