ACETAMINOPHEN
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acetaminophen tablet
TIME CAP LABS INC
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.
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LIVER WARNING: THIS PRODUCT CONTAINS ACETAMINOPHEN. SEVERE LIVER DAMAGE MAY OCCUR IF YOU TAKE:
More than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen;3 or more alcoholic drinks every day while using this product.
USES;
Temporarily relieves minor aches and pains due to: The common cold; backache; minor pain of arthritis; muscular aches;premenstrual cramps;temporarily reduces fever; headache;toothache
DO NOT USE: With other drugs containing acetaminophen(prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Stop Use and ask a doctor if: Pain gets worse or lasts more than 10 days; fever gets worse or last more than 3 days, new symptoms occur; redness or swelling is present; these could be signs of a serious condition.
DIRECTIONS;
DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)
Adults and children 12 years and over: take 2 tablets every 4-6 hours while symptoms last
Do not take more than 8 tablets in 24 hours
Do not use for more than 10 days unless directed by a doctor
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 may cause liver damage
Overdose Warning; Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults was well as children even if you do not notice any signs or symptoms.
ACETAMINOPHEN
acetaminophen tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part343 | 07/12/2011 |
Labeler - TIME CAP LABS INC (037052099) |
Establishment | |||
Name | Address | ID/FEI | Operations |
TIME CAP LABS INC | 037052099 | manufacture |
Revised: 07/2011 TIME CAP LABS INC