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  5. Label Information: Robitussin Direct Chest Congestion

FDA Label for Robitussin Direct Chest Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. ADDITIONAL INFORMATION
    14. PRINCIPAL DISPLAY PANEL

Robitussin Direct Chest Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings 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 (in each tablet)

Guaifenesin 400 mg


Otc - Purpose



Purpose

Expectorant


Indications & Usage



Use

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


Warnings



Warnings


Ask A Doctor Before Use If You Have



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

Otc - Stop Use



Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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.


Dosage & Administration



Directions

  • •take with a full glass of water
  • •do not take more than 6 tablets in 24 hours
  • •do not take more than directed

    • adults and children 12 years and over

    take 1 tablet every 4 hours

    children under 12 years

    Do not use


Storage And Handling



Other information

  • •store at 20°-25°C (68°-77°F)

Inactive Ingredient



Inactive ingredients

FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid


Otc - Questions



Questions or comments?

Call weekdays from 9 AM-5 PM EST at 1-800-245-1040


Additional Information



Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Lift Here for More Drug Facts

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor.

Made in China


Principal Display Panel



NEW

Robitussin

Chest Congestion

Guaifenesin
(Expectorant)

direct

Actual size

18
Tablets
L-0630-532-44-UPC_ORG Front Label

Robitussin Direct Chest Congestion 18 tablets - image 01

Robitussin Direct Chest Congestion 18 tablets - image 01


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