FAMOTIDINE - famotidine tablet, film coated 
Aurohealth LLC

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Drug Facts

Active ingredient (in each tablet)

Famotidine USP 20 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, titanium dioxide and yellow iron oxide.

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 -20 mg (50 Tablets, Container Label)

AUROHEALTH
NDC 58602-706-14

MAXIMUM STRENGTH
Famotidine
Tablets USP 20 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

50 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label)


AUROHEALTH

NDC 58602-706-14
*Compare to the Active Ingredient
of Maximum Strength Pepcid® AC
MAXIMUM STRENGTH

Famotidine
Tablets USP
20 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

50 Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label)





PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg Blister Carton 25 Tablets


AUROHEALTH

NDC 58602-706-62
*Compare to the Active
Ingredient of Maximum
Strength Pepcid® AC
MAXIMUM STRENGTH
Famotidine
Tablets USP
20 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

25 Tablets

famotidine-20mg-fig3.jpg

FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-706
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUND (Square shaped Biconvex) Size5mm
FlavorImprint Code CC;59
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-706-531 in 1 CARTON04/26/2016
125 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-706-561 in 1 CARTON04/26/2016
235 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-706-141 in 1 CARTON04/26/2016
350 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-706-161 in 1 CARTON04/26/2016
465 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:58602-706-541 in 1 CARTON04/26/2016
570 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:58602-706-471 in 1 CARTON04/26/2016
675 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:58602-706-181 in 1 CARTON04/26/2016
780 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:58602-706-501 in 1 CARTON04/26/2016
885 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:58602-706-211 in 1 CARTON04/26/2016
9100 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:58602-706-625 in 1 CARTON04/26/2016
10NDC:58602-706-605 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:58602-706-94100 in 1 BOTTLE; Type 0: Not a Combination Product04/26/2016
12NDC:58602-706-791 in 1 CARTON04/26/2016
128 in 1 BLISTER PACK; Type 0: Not a Combination Product
13NDC:58602-706-152 in 1 CARTON02/24/2020
138 in 1 BLISTER PACK; Type 0: Not a Combination Product
14NDC:58602-706-341 in 1 CARTON07/22/2020
14200 in 1 BOTTLE; Type 0: Not a Combination Product
15NDC:58602-706-391 in 1 CARTON07/22/2020
15365 in 1 BOTTLE; Type 0: Not a Combination Product
16NDC:58602-706-441 in 1 CARTON07/22/2020
16400 in 1 BOTTLE; Type 0: Not a Combination Product
17NDC:58602-706-401 in 1 CARTON07/22/2020
17500 in 1 BOTTLE; Type 0: Not a Combination Product
18NDC:58602-706-88750 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
19NDC:58602-706-411000 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
20NDC:58602-706-191 in 1 CARTON01/08/2021
2090 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(58602-706) , MANUFACTURE(58602-706)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-706) , MANUFACTURE(58602-706)

Revised: 4/2022
Document Id: e2591701-c1be-44d3-af95-4c3275b00d5a
Set id: f2b911c7-ce24-4d3d-8fb6-c34980191f40
Version: 13
Effective Time: 20220428
 
Aurohealth LLC