FDA Label for Acetaminophen And Diphenhydramine Hydrochloride

The following document was submitted to the FDA by the labeler of this product Granules India Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

Package Label.Principal Display Panel

APAP-Diphen-664-35 - APAP Diphen 664 35

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