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  5. Label Information: Guaifenesin

FDA Label for Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. DESCRIPTION
    3. INACTIVE INGREDIENTS
    4. USES
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. PROFESSIONAL NOTE
    10. DIRECTIONS
    11. STORAGE
    12. PRINCIPAL DISPLAY PANEL

Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. 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.

Otc - Purpose



Expectorant
SUGAR FREE / ALCOHOL FREE


Description



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


Inactive Ingredients



Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

Sodium Content: 4 mg/5 mL


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.
  • •you are hypersensitive to any of the ingredients.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Professional Note



Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).


Directions



Follow dosage below or use as directed by a physician.

  • •do not take more than 6 doses in any 24-hour period.
    • agedose

    adults and children 12 years and over

    10 to 20 mL
    (2 to 4 teaspoonfuls)
    every 4 hours

    children 6 years to under 12 years

    5 to 10 mL
    (1 to 2 teaspoonfuls)
    every 4 hours

    children 2 to under 6 years of age

    2.5 to 5 mL
    (½ to 1 teaspoonful)
    every 4 hours

    children under 2 years of age

    consult a physician


Storage



Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.


Principal Display Panel



Guaifenesin Oral Solution, USP

200/10 mL

5 cups


* Please review the disclaimer below.