FAMOTIDINE - famotidine tablet, film coated 
Aurohealth LLC

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Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 mg

Purpose

Acid reducer

Uses


Warnings


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

Do not use


Ask a doctor before use if you have

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


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


Other information


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
 

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
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

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 Label)

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

famotidine-fig2.jpg



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-fig3.jpg




FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-705
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeROUND (biconvex) Size5mm
FlavorImprint Code CC;58
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-705-151 in 1 CARTON04/26/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-705-191 in 1 CARTON04/26/2016
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-705-841 in 1 CARTON05/13/2019
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-705-093 in 1 CARTON04/26/2016
4NDC:58602-705-0310 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:58602-705-124 in 1 CARTON04/26/2016
5NDC:58602-705-0310 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:58602-705-9390 in 1 BOTTLE; Type 0: Not a Combination Product04/26/2016
7NDC:58602-705-141 in 1 CARTON12/21/2019
750 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:58602-705-341 in 1 CARTON07/22/2020
8200 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:58602-705-391 in 1 CARTON07/22/2020
9365 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:58602-705-441 in 1 CARTON07/22/2020
10400 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:58602-705-401 in 1 CARTON07/22/2020
11500 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:58602-705-881 in 1 CARTON07/22/2020
12750 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC:58602-705-411 in 1 CARTON09/04/2020
131000 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC:58602-705-321 in 1 CARTON02/18/2022
14180 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653104/26/2016
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-705) , MANUFACTURE(58602-705)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-705) , MANUFACTURE(58602-705)

Revised: 4/2022
Document Id: eae812ef-42f7-4f61-8b94-fea12e621da0
Set id: 756c7234-6a63-4b1b-be36-2b1ed09e67a0
Version: 12
Effective Time: 20220428
 
Aurohealth LLC