ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE- acetaminophen and diphenhydramine hydrochloride capsule 
Granules India Limited

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Acetaminophen and Diphenhydramine Hydrochloride Rapid Relese Gelcaps

ACETAMINOPHEN 500 mg & DIPHENHYDRAMINE HCl 25 mg

RAPID RELEASE GELCAPS

Each Rapid Release Gelcap Contains:
Acetaminophen USP 500 mg and Diphenhydramine Hydrochloride USP 25 mg

BOX LABEL

Batch No.:XXXNo. of Units5 x 5000
Mfg. Dt.:MMM/YYYYGross Wt.:0.00 kg
Exp. Dt.:MMM/YYYYTare Wt:. 0.00 kg
Mfg. Lic. No.:37/RR/AP/2003/F/RNet Wt.:0.00 kg
NDC No.XXXXX-XXX-XXBox Number:000
Storage:Store at 20 – 25C (68 – 77F); excursions permitted to 15 – 30 C (59 – 86F); Preserve in tightly closed containers.
CautionFor Repacking only.

POUCH LABEL

Batch No.:XXXNo. of Units5000
Mfg. Dt.:MMM/YYYY
Exp. Dt.:MMM/YYYY
Mfg. Lic. No.:37/RR/AP/2003/F/R
NDC No.XXXXX-XXX-XX
Storage:Store at 20 – 25C (68 – 77F); excursions permitted to 15 – 30 C (59 – 86F); Preserve in tightly closed containers.
CautionFor Repacking only.

Gil/PL/041

Product Code: XXXXXXX

Manufactured in India by:
Granules India Limited
Plot No. 160/A, 161/E, Gagillapur Village
Qutbullapur Mandal, Ranga Reddy Dt – 500 043, AP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP-Diphen-664-35APAP-Diphen-664-3106259b5e-figure-01

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride capsule
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-664
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYDROXYPROPYL CELLULOSE (1200000 WAMW) (UNII: U3JF91U133)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
TRIACETIN (UNII: XHX3C3X673)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SHELLAC (UNII: 46N107B71O)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorblue (dark blue/light blue) Scoreno score
ShapeCAPSULE (banded two-part capsule) Size20mm
FlavorImprint Code G;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-664-215000 in 1 BOX01/14/2014
2NDC:62207-664-2225000 in 1 BOX01/14/2014
3NDC:62207-664-2330000 in 1 BOX01/14/2014
4NDC:62207-664-315000 in 1 POUCH01/14/2014
5NDC:62207-664-3210000 in 1 POUCH01/14/2014
6NDC:62207-664-3325000 in 1 POUCH01/14/201411/13/2019
7NDC:62207-664-3525000 in 1 BOX11/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/14/2014
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-664) , analysis(62207-664)

Revised: 8/2023
Document Id: 0435fe4c-54fe-763a-e063-6394a90ac0f0
Set id: 1d42ed62-3ea7-478e-b77e-438bd2b49765
Version: 7
Effective Time: 20230831
 
Granules India Limited