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  5. Label Information: Guaifenesin

FDA Label for Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. GUAIFENESIN
    2. DESCRIPTION
    3. INACTIVE INGREDIENTS
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. PRINCIPAL DISPLAY PANEL - 5 ML UNIT DOSE CUP LABEL
    8. PRINCIPAL DISPLAY PANEL - 10 ML UNIT DOSE CUP LABEL

Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Kesin Pharma 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.

Guaifenesin



Expectorant
Sugar Free / Dye Free / Alcohol Free


Description



Each 5mL (1 teaspoonful) contains: Guaifenesin 100mg


Inactive Ingredients



Mixture of Guaifenesin with GRAS material additions including Citric Acid, Grape Flavor Methylparaben, Monoammonium Glycyrrhizate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose


Uses



Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.


Warnings



Ask a doctor before us if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Directions



Follow dosage below or use as directed by a physician.
Do not take more than 6 doses in any 24-hour period

Age Dose
 Adults and children 12 years and over 10 to 20mL (2 to 4 teaspoonfuls) every 4 hours
 Children 6 years to under 12 years 5 to 10mL (1 to 2 teaspoonfuls) every 4 hours
 Children 2 to under 6 years of age 2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours
 Children under 2 years of age Consult a physician


Principal Display Panel - 5 Ml Unit Dose Cup Label



NDC 81033-102-51

Guaifenesin Oral Solution, USP

Delivers 100mg per 5mL

FOR INSTITUTIONAL USE ONLY

50 X 5 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

5 mL cup label - 5ml

5 mL cup label - 5ml


Principal Display Panel - 10 Ml Unit Dose Cup Label



NDC 81033-102-52

Guaifenesin Oral Solution, USP

Delivers 200mg per 10mL

FOR INSTITUTIONAL USE ONLY

50 X 10 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

10 mL cup label - 10ml

10 mL cup label - 10ml


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