FDA Label for Guaifenesin Strawberry-banana Flavor

View Indications, Usage & Precautions

Guaifenesin Strawberry-banana Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Innovida Pharmaeutique Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Guaifenesin,USP 100 mg (in each 5ml tsp)


Purpose



Expectorant


Uses



  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings



Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop use and ask a doctor if■ cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



  • Do not take more than 6 doses in any 24 hours period
  •  age dose

     Adults and Children 12 years of age and over:

    Children under 12 years of age:

     Take 2-4 teaspoonful (5mL) every 4 hours

    Consult a physician


Other Information



  • store at room temperature ■ 15°-30°C (59°-86°F)
  • TAMPER-EVIDENT: Do not use if seal under cap is torn, broken or missing.

Inactive Ingredients



Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.


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