Bionel Recall

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Questions & Answers

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Side Effects & Adverse Reactions

Warnings
Do not use if you are now taking a prescription
Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression,
psychiatric, or emotional conditions or Parkinson’s disease), or for
2 weeks after stopping the MAOI drug. If you do not know if you are
taking a prescription drug that contains a MAOI; ask a doctor or
pharmacist before taking this product.

Ask a doctor before use if you hav e

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to the enlargement of the prostate gland
  
• a cough that occurs with too much phlegm (mucus)
  
• a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or accompanied by fever
  
• cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
  

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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

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• store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
  

Warning: Phenylketonuric: Contains 19 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

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History

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Other Information

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