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  5. Label Information: Guaifenesin

FDA Label for Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. STOP USE AND ASK A DOCTOR IF
    6. IF PREGNANT OR BREAST-FEEDING,
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL

Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Oncor Pharmaceuticals. 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 (In Each 5 Ml Teaspoonful)



Guaifenesin 100 mg


Purpose



Expectorant


Uses



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

Ask A Doctor Before Use 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

Stop Use And Ask A Doctor If



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.


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



  • do not take more than 6 doses in any 24-hour period
     Age   Dose
     Adults and Children 12 years and over 2-4 Teaspoonfuls every 4 hours
     Children 6 years to under 12 years 1-2 Teaspoonfuls every 4 hours
     Children 2 years to under 6 years 1/2-1 Teaspoonful every 4 hours
     Under 2 years Ask a doctor

    • Drug Facts(continued)


Other Information



  • store at 20°-25°C (68°-77°F)
  • Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
  • sodium content 3 mg/5 mL

Inactive Ingredients



Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.


Questions?



You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Manufactured for:
Oncor Pharmaceuticals
8815 Center Park Dr. Suite 430
Columbia, Maryland 21045


Rev. 05/24


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