Bionel
FDA Label NDC 45737-207

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Bionel (NDC 45737-207). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients: (in each 5 mL tsp.)              Purpose

Guaifenesin 50 mg .............................................. Expectorant

Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant

Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant

Otc - Purpose

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves these symptoms occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.

Warnings

Warnings
Do not use in a child who is 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.

Otc - Do Not Use

Ask a doctor before use if your child have
  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Dosage & Administration

Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hoursChildren 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hoursChildren under 2 years of age; Under 25 lbs; Ask a doctor

Indications & Usage

Other information
  • 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 14 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

Inactive Ingredient

Inactive ingredients aspartame, citric acid, corn syrup, D and C Red No 33, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water.

Otc - Questions

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

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Bionelpedlabel (Bionelpedlabel)

Bionelpedlabel (Bionelpedlabel)

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