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  5. Label Information: Chest Congestion Relief

FDA Label for Chest Congestion Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. OTC - QUESTIONS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chest Congestion Relief Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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 ingredients

Guaifenesin 100 mg


Otc - Purpose



Purpose

Expectorant


Indications & Usage



Uses

helps lossen phlegm (mucus) and thin bronchial secretions to make coughs more productive


Warnings



Warnings

Do not use if you ever had an allergic reaction to any of the indregients in this product

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.


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 (1-800-222-1222) right away.


Dosage & Administration



Directions

  • Do not take more than 6 doses in a 24 hour period
  • Do not exceed recommended dose
    •  Adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours
     children under 12 years ask a doctor


Inactive Ingredient



Inactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, sucralose


Otc - Questions



Questions or comments? 1-800-645-2158


Package Label.Principal Display Panel



image description - chestcongestions

image description - chestcongestions


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