ACETAMINOPHEN RAPID RELEASE- acetaminophen capsule, gelatin coated 
Granules India Limited

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Acetaminophen Rapid Release Gelcaps

ACETAMINOPHEN RAPID RELEASE GELCAPS 500 MG

Each rapid release gelcap contains
Acetaminophen USP 500 mg

Batch No.:XXXNo. of Units5 x 5000 Gelcaps
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.

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-gelcaps-31

apap-gelcaps-35

62207-167-11

ACETAMINOPHEN  RAPID RELEASE
acetaminophen capsule, gelatin coated
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-167
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN499.5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
Colorred, blue (blue-gray) Scoreno score
ShapeCAPSULE (banded two-part capsule) Size19mm
FlavorImprint Code G;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-167-215000 in 1 BOX10/29/2013
2NDC:62207-167-2225000 in 1 BOX10/29/2013
3NDC:62207-167-315000 in 1 POUCH10/29/2013
4NDC:62207-167-3210000 in 1 POUCH10/29/2013
5NDC:62207-167-3325000 in 1 POUCH10/29/2013
6NDC:62207-167-3525000 in 1 BOX10/29/2013
7NDC:62207-167-1139806 in 1 DRUM05/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only10/29/2013
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-167) , analysis(62207-167)

Revised: 1/2023
Document Id: f33acdb8-e036-6b48-e053-2a95a90a867d
Set id: 140244ec-5bd2-4713-a491-457c4dd90fcb
Version: 9
Effective Time: 20230127
 
Granules India Limited