FDA Label for Guaifenesin

View Indications, Usage & Precautions

Guaifenesin 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 200 mg


Purpose



Expectorant


Uses



  • helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes

Warnings



ASK A DOCTOR BEFORE USE IF

  • cough that occurs with too much phlegm(mucus) 
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • STOP USE AND ASK DOCTOR IFcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

    IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml=milliliter
  • this adult product is not intended for use in children under 12 years of age
  •  age dose

     adults and children 12 years and over

    children under 12 years

     20 mL every 4 hours

     do not use


Other Information



Store between 20° to 25°C (68° to 77°F)


Inactive Ingredients



caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate.


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Product Label




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