Guaifenesin Strawberry-banana Flavor Liquid
FDA Label NDC 71800-059

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovida Pharmaeutique Corporation for the product Guaifenesin Strawberry-banana Flavor (NDC 71800-059). 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 active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments? 1-888-462-4166, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Questions Or Comments? 1-888-462-4166

Product Label

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Image Description (Image 59)

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