FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Granules India Limited | GRANULES LIFE SCIENCES PRIVATE LIMITED
Effective date
2024-08-14
Label type
BULK INGREDIENT
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 20:56:44

Label at a glance#

ProductAcetaminophen Rapid Release
Active ingredientACETAMINOPHEN
Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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-31apap-gelcaps-31

apap-gelcaps-35apap-gelcaps-35

62207-167-1162207-167-11

62207-167-11-gls62207-167-11-gls

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-16762207-167-21, 62207-167-22, 62207-167-31, 62207-167-32, 62207-167-33, 62207-167-35, 62207-167-11

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
GELATIN2G86QN327LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C RED NO. 339DBA0SBB0LIACT
ISOPROPYL ALCOHOLND2M416302IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMMONIA5138Q19F1XIACT
ALCOHOL3K9958V90MIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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