Phazyme

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Phazyme Recall

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Side Effects & Adverse Reactions

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condition persists

Keep out of reach of children.

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condition persists

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

•: relieves bloating, pressure or fullness commonly referred to as gas

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History

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Sources

Phazyme Manufacturers

Preferred Pharmaceuticals, Inc.

Phazyme | Preferred Pharmaceuticals, Inc.

• swallow one or two softgels as needed after a meal
• do not exceed two softgels per day except under the advice and supervision of a physician

No Recall
Preferred Pharmaceuticals, Inc

Phazyme | Fresenius Kabi Usa, Llc

Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of Tranexamic Acid Injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.

Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:

Serum Creatinine (μmol/L)

Tranexamic Acid I.V. Dosage

120 to 250 (1.36 to 2.83 mg/dL)

10 mg/kg BID

250 to 500 (2.83 to 5.66 mg/dL)

10 mg/kg daily

10 mg/kg every 48 hours

>500 (>5.66 mg/dL)

or

5 mg/kg every 24 hours

For intravenous infusion, Tranexamic Acid Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to Tranexamic Acid Injection. Tranexamic Acid Injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.

No Recall
Medtech Products Inc.

Phazyme | Medtech Products Inc.

swallow one or two softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

No Recall
Glaxosmithkline Consumer Healthcare Lp

Phazyme | Glaxosmithkline Consumer Healthcare Lp

• swallow one or two softgels as needed after a meal • do not exceed two softgels per day except under the advice and supervision of a physician

No Recall
C.b. Fleet Company, Inc.

Phazyme | C.b. Fleet Company, Inc.

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

No Recall
C.b. Fleet Company, Inc.

Phazyme | C.b. Fleet Company, Inc.

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

No Recall
C.b. Fleet Company, Inc.

Phazyme | C.b. Fleet Company, Inc.

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

No Recall
C.b. Fleet Company, Inc.

Phazyme | C.b. Fleet Company, Inc.

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

No Recall