Acetaminophen Rapid Release Gelcaps

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.:	XXX	No. of Units	5 x 5000 Gelcaps
Mfg. Dt.:	MMM/YYYY	Gross Wt.:	0.00 kg
Exp. Dt.:	MMM/YYYY	Tare Wt.:	0.00 kg
Mfg. Lic. No.:	37/RR/AP/2003/F/R	Net Wt.:	0.00 kg
NDC No.	XXXXX-XXX-XX	Box number:	000
Storage:	Store at 20 – 25C (68 – 77F); excursions permitted to 15 – 30 C (59 – 86F); Preserve in tightly closed containers.
Caution	For 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

ACETAMINOPHEN  RAPID RELEASE
acetaminophen capsule, gelatin coated

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-167

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	499.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red, blue (blue-gray)	Score	no score
Shape	CAPSULE (banded two-part capsule)	Size	19mm
Flavor		Imprint Code	G;1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-167-21	5000 in 1 BOX	10/29/2013
2	NDC: 62207-167-22	25000 in 1 BOX	10/29/2013
3	NDC: 62207-167-31	5000 in 1 POUCH	10/29/2013
4	NDC: 62207-167-32	10000 in 1 POUCH	10/29/2013
5	NDC: 62207-167-33	25000 in 1 POUCH	10/29/2013
6	NDC: 62207-167-35	25000 in 1 BOX	10/29/2013
7	NDC: 62207-167-11	39806 in 1 DRUM	05/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		10/29/2013

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-167) , analysis(62207-167)

Establishment
Name	Address	ID/FEI	Business Operations
GRANULES LIFE SCIENCES PRIVATE LIMITED		644776835	manufacture(62207-167) , pack(62207-167) , label(62207-167)

Revised: 8/2024

Document Id: 1fa1ee2f-e3eb-f32e-e063-6394a90ae940

53409-9

Set id: 140244ec-5bd2-4713-a491-457c4dd90fcb

Version: 10

Effective Time: 20240814