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Flextra-650 (Acetaminophen / Phenyltoloxamine Citrate) - Warnings and Precautions

 
 



Laboratory Test:

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No adequate studies have been conducted in animals to determine whether Phenyltoloxamine Citrate or Acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Teratogenic Effects: Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Acetaminophen is excreted in breast milk in small amounts but the significance of its effect on nursing infants in not knows. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Phenyltoloxamine Citrate and Acetaminophen, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in the pediatric population have not been established.

Warnings:

Do not take this product for pain for more than 10 days (adults) or 5 days (children) unless directed by a physician, and do not take for fever for more than 3 days unless directed by a physician. If pain of fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness: alcohol,  sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedative, or tranquilizers, without first consulting a physician. Use caution when driving a motor vehicle or operating machinery.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health professional before using this product.

Page last updated: 2001-04-16

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