Label: ACETAMINOPHEN tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 65437-040-31, 65437-040-50 - Packager: HIMPRIT PHARMACHEM PVT LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 20, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each Caplet)
- Purpose
- Uses
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Warnings
Overdose Warning
Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even you do not notice any signs or symptoms.
Alcohol Warnings
If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
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Direction
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- do not use more that directed (see overdose warning)
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- adults and children 12 years and over : take 2 caplets every 6 hours as needed
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- do not take more than 8 caplets in 24 hours
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- Children under 12 years : do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 500 mg Tablet Shipper Label
ACETAMINOPHEN TABLETS USP 500 mg
Each Film coated Tablet Contains:
ACETAMINOPHEN 500 MGLot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 31000 Tablets
NDC. No : 65437-040-31WARNING :
KEEP OUT OF THE REACH OF CHILDRENSTORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZINGTHIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDERMANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength SODIUM METABISULFITE (UNII: 4VON5FNS3C) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score no score Shape OVAL Size 18mm Flavor Imprint Code S;500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65437-040-31 1 in 1 DRUM 1 31000 in 1 BAG 2 NDC:65437-040-50 1 in 1 DRUM 2 50000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 07/01/2010 Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)