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  5. Label Information: Childrens Mucus Relief Chest Congestion

FDA Label for Childrens Mucus Relief Chest Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Childrens Mucus Relief Chest Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Manufacturing Assn. 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.

Other



Drug Facts


Active Ingredient (In Each 5 Ml)



Guaifenesin, USP 100 mg


Purpose



Expectorant


Uses



helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


Otc - Ask Doctor



Ask a doctor before use if the child has

  • •cough that occurs with too much phlegm (mucus)
  • •persistent or chronic cough such as occurs with asthma

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.


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.


Directions



  • •do not take more than 6 doses in any 24-hour period
  • •measure only with dosing cup provided
  • •do not use dosing cup with other products
  • •mL = milliliter
    • AgeDose

    children 6 years to under 12 years

    5 mL – 10 mL every 4 hours

    children 4 years to under 6 years

    2.5 mL – 5 mL every 4 hours

    children under 4 years

    do not use


Other Information



  • •each 5 mL contains: sodium 3 mg
  • •Tamper evident: do not use if printed inner seal under cap is torn or missing.
  • •store at room temperature
  • •do not refrigerate
  • •dosing cup provided

Inactive Ingredients



anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.


Principal Display Panel - 118 Ml Bottle Carton



QC QUALITY CHOICE NDC 63868-770-04

Children's
Mucus relief

Expectorant

Guaifenesin

Oral Solution, USP

Each Dose of Grape Flavored

Children’s Mucus Relief:

Relieves Chest Congestion

* Please review the disclaimer below.