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  5. Label Information: Robitussin Mucus Plus Chest Congestion

FDA Label for Robitussin Mucus Plus Chest Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 10 ML)
    3. PURPOSE
    4. USE
    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 OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
    14. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Robitussin Mucus Plus Chest Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Richmond Division Of Wyeth. 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:
Pfizer, Madison, NJ 07940 USA

For most recent product information, visit www.robitussin.com


Active Ingredient (In Each 10 Ml)



Guaifenesin, USP 200 mg


Purpose



Expectorant


Use



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 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 right away.


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 over10-20 ml every 4 hours
    children under 12 yearsdo not use

Other Information



  • each 10 ml contains: sodium 4 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • alcohol-free

Inactive Ingredients



anhydrous citric acid, artificial flavor, caramel, FD&C red no. 40, glycerin, high fructose corn syrup, liquid glucose, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate


Questions Or Comments?



Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675


Principal Display Panel - 118 Ml Bottle Label



ADULT

Robitussin®

Mucus + Chest Congestion

GUAIFENESIN (Expectorant)

Alcohol-Free

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label - robitussin 01

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label - robitussin 01


Principal Display Panel - 118 Ml Bottle Carton



ADULT

Robitussin®

Mucus + Chest
Congestion

GUAIFENESIN (Expectorant)

Relieves:

* Please review the disclaimer below.