Acetaminophen Rapid Release: Package Insert and Label Information

ACETAMINOPHEN RAPID RELEASE- acetaminophen capsule, gelatin coated
Granules India Limited

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

apap-gelcaps-31
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apap-gelcaps-35
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62207-167-11
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ACETAMINOPHEN RAPID RELEASE
acetaminophen capsule, gelatin coated
Product Information
Product Type BULK INGREDIENT Item Code (Source) NHRIC:62207-167
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 499.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POVIDONE K30
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
STEARIC ACID
HYPROMELLOSE 2910 (3 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
GELATIN
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
D&C RED NO. 33
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
ALCOHOL
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 Multilevel Packaging
1 NHRIC:62207-167-21 5000 CAPSULE, GELATIN COATED in 1 BOX None
2 NHRIC:62207-167-22 25000 CAPSULE, GELATIN COATED in 1 BOX None
3 NHRIC:62207-167-31 5000 CAPSULE, GELATIN COATED in 1 POUCH None
4 NHRIC:62207-167-32 10000 CAPSULE, GELATIN COATED in 1 POUCH None
5 NHRIC:62207-167-33 25000 CAPSULE, GELATIN COATED in 1 POUCH None
6 NHRIC:62207-167-35 25000 CAPSULE, GELATIN COATED in 1 BOX None
7 NHRIC:62207-167-11 39806 CAPSULE, GELATIN COATED in 1 DRUM None
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 Operations
Granules India Limited 918609236 manufacture (62207-167), analysis (62207-167)

Revised: 09/2022 Granules India Limited

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