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.:	XXX	No. of Units	5 x 5000
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.

POUCH LABEL

Batch No.:	XXX	No. of Units	5000
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.
Caution	For 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.

APAP-Diphen-664-35 APAP-Diphen-664-31 06259b5e-figure-01

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen and diphenhydramine hydrochloride capsule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:62207-664

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	blue (dark blue/light blue)	Score	no score
Shape	CAPSULE (banded two-part capsule)	Size	20mm
Flavor		Imprint Code	G;3
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62207-664-21	5000 in 1 BOX	01/14/2014
2	NDC:62207-664-22	25000 in 1 BOX	01/14/2014
3	NDC:62207-664-23	30000 in 1 BOX	01/14/2014
4	NDC:62207-664-31	5000 in 1 POUCH	01/14/2014
5	NDC:62207-664-32	10000 in 1 POUCH	01/14/2014
6	NDC:62207-664-33	25000 in 1 POUCH	01/14/2014	11/13/2019
7	NDC:62207-664-35	25000 in 1 BOX	11/14/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		01/14/2014

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Name	Address	ID/FEI	Business Operations
Establishment
Granules India Limited		918609236	manufacture(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