1. Home
  2. Labeler Index
  3. Haleon Us Holdings Llc
  4. 0031-9302
  5. Label Information: Robitussin Direct Cough

FDA Label for Robitussin Direct Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. ADDITIONAL INFORMATION
    15. PRINCIPAL DISPLAY PANEL

Robitussin Direct Cough 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 liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg


Otc - Purpose



Purpose

Cough suppressant


Indications & Usage



Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.


Warnings



Warnings


Otc - Do Not Use



Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


Ask A Doctor Before Use If You Have



  • •a cough that occurs with too much phlegm (mucus)
  • •a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Otc - Stop Use



Stop use and ask a doctor if cough lasts for 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.


Dosage & Administration



Directions

  • •do not take more than 8 capsules in any 24-hour period
  • •this adult product is not intended for use in children under 12 years of age

    • adults and children 12 years and over

    take 1 capsule (15 mg) every 4 hours, as required

    children under 12 years

    do not use


Storage And Handling



Other information

  • •store at 20°C-25°C (68°F -77°F)
  • •avoid excessive heat above 40°C (104°F)
  • •protect from light

Inactive Ingredient



Inactive ingredients

FD&C blue no. 1, FD&C red no. 40, fractionated coconut oil, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol, sorbitol anhydrides


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.

Should be 18 or older to purchase

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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 India


Principal Display Panel



NEW

Robitussin

Cough

Dextromethorphan HBr
(Cough Suppressant)

direct

Actual size

18
Liqui-Gels®*
*Liquid filled capsules

L-0630-782-44-UPC_ORG Front Label

Robitussin Direct Cough 18 liqui gels - image 01

Robitussin Direct Cough 18 liqui gels - image 01


* Please review the disclaimer below.