FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Himprit Pharmachem Pvt Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/ fever reducer
Uses
Temporarily relieves minor aches and pains due to :
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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.
Otc - Do Not Use
Do not use
* with any other product containing acetaminophen
Otc - Stop Use
Stop use and Ask a doctor if
* fever gets worse or lasts for more than 3 days* redness or swelling is present* pain gets worse or lasts for more than 10 days* new symptoms occur
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Direction
* do not use more that directed (see overdose warning)* adults and children 12 years and over : take 2 caplets every 6 hours as needed* do not take more than 8 caplets in 24 hours* 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
* Store at room temperature
Inactive Ingredients
croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate
Principal Display Panel - 500 Mg Tablet Shipper Label
ACETAMINOPHEN TABLETS USP 500 mg
Each Film coated Tablet Contains:
ACETAMINOPHEN 500 MG
Lot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 31000 Tablets
NDC. No : 65437-040-31
WARNING :
KEEP OUT OF THE REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS 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 THEREUNDER
MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803
MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.