OTC Medication Information: Acetaminophen 500 Mg Round

ACETAMINOPHEN 500 MG ROUND- acetaminophen tablet
Granules India Limited

apap-500-mg-red
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ACETAMINOPHEN 500 MG ROUND
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NHRIC:62207-538
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
LECITHIN, SOYBEAN
FD&C RED NO. 40
POVIDONE K30
FD&C YELLOW NO. 6
STARCH, CORN
SUCRALOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 11mm
Flavor Imprint Code L;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:62207-538-87 15000 TABLET in 1 BOX None
2 NHRIC:62207-538-85 90000 TABLET in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 02/13/2023
Labeler — Granules India Limited (915000087)
Registrant — Granules India Limited (918609236)
Establishment
Name Address ID/FEI Operations
Granules India Limited 918609236 manufacture (62207-538), analysis (62207-538), pack (62207-538), label (62207-538)

Revised: 01/2023 Granules India Limited

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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