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  5. Label Information: Robitussin Long-acting Coughgels

FDA Label for Robitussin Long-acting Coughgels

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL - 20 CAPSULE BOTTLE LABEL
    16. PRINCIPAL DISPLAY PANEL - 20 CAPSULE BOTTLE CARTON

Robitussin Long-acting Coughgels 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.

Other



Drug Facts

Distributed by: Pfizer, Madison, NJ 07940 USA


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
    • agedose
    adults and children 12 years and overtake 2 capsules every 6 to 8 hours, as needed
    children under 12 yearsdo not use

Storage And Handling



Other information

  • store at 20-25°C (68-77°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 1-800-762-4675


Principal Display Panel - 20 Capsule Bottle Label



ADULT

Robitussin®

Long-Acting CoughGels®

DEXTROMETHORPHAN HBr (Cough Suppressant)

Non-Drowsy
Formula

UP
TO
8 HR
RELIEF

20
LIQUI-GELS®*
*Liquid-Filled Capsules


Principal Display Panel - 20 Capsule Bottle Carton



ADULT
NEW LOOK!

Robitussin®

Long-Acting
CoughGels®

DEXTROMETHORPHAN HBr
(Cough Suppressant)

UP
TO
8 HR
RELIEF

Non-Drowsy
Formula

For Ages 12 & Over

20
LIQUI-GELS®*
*LIQUID FILLED CAPSULES


* Please review the disclaimer below.