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  5. Label Information: Healthmart Chest Congestion Relief

FDA Label for Healthmart Chest Congestion Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthmart Chest Congestion Relief Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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 - Active Ingredient



Active ingredient (per tablet)

Guaifenesin  400mg


Purpose



Expectorant


Uses



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

Warnings



Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Otc - Stop Use



Stop use and ask doctor if

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur
    • A persistent cough may be a sign of a serious condition.

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 immediately.


Directions



  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor    
    • Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information



store at 15°-30°C (59°-86°F)


Inactive Ingredients



magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.


Package Label.Principal Display Panel



image of carton label - carton

image of carton label - carton


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