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  5. Label Information: Rugby Cough Guaifenesin

FDA Label for Rugby Cough Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 10 ML)
    3. PURPOSE
    4. USES
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. HOW SUPPLIED

Rugby Cough Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Unit Dose Services. 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

Distributed by:
Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Re-order No.370448

Rev.10/15

R-107


Active Ingredient (In Each 10 Ml)



Guaifenesin, USP 200 mg


Purpose



Expectorant


Uses



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


Otc - Ask Doctor



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

Otc - Stop Use



Stop use and ask a doctor if cough last 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 right away at 1-800-222-1222.


Directions



  • •do not take more than 6 doses in any 24-hour period
  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •mL=milliliter
  • •this adult product is not intended for use in children under 12 years of age
    • agedose

    adults and children 12 years and over

    10 mL-20 mL every 4 hours

    children under 12 years

    do not use


Other Information



  • •each 10 mL contains:sodium 4 mg
  • •store at 20-25°C (68-77°F).
  • •alcohol-free

Inactive Ingredients



citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.


Questions?



1-866-467-2748


How Supplied



Product: 50436-1095

NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE


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