Acetaminophen and Diphenhydramine Hydrochloride

Manufacturer
Granules India Limited
Effective date
2023-08-31
Label type
BULK INGREDIENT
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:26:37

Label at a glance#

ProductAcetaminophen and Diphenhydramine Hydrochloride
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

ACETAMINOPHEN 500 mg & DIPHENHYDRAMINE HCl 25 mg

SPL UNCLASSIFIED SECTION

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-664-35APAP-Diphen-664-31APAP-Diphen-664-3106259b5e-figure-0106259b5e-figure-01

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-66462207-664-21, 62207-664-22, 62207-664-23, 62207-664-31, 62207-664-32, 62207-664-33, 62207-664-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYb9b86755-63ad-e25a-e053-2995a90ad7472024-09-10WarningsName fallback
brand name: Acetaminophen and Diphenhydramine hydrochloride
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.16d5786c-2346-f970-e063-6394a90a0a8c2024-07-03WarningsName fallback
brand name: Acetaminophen and Diphenhydramine hydrochloride
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAurohealth LLC3ba51b52-7ae6-4335-b178-1b7b6ef362272023-11-29WarningsName fallback
brand name: Acetaminophen and Diphenhydramine hydrochloride
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsName fallback
brand name: Acetaminophen and Diphenhydramine hydrochloride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.