Robitussin Long-acting Coughgels Capsule, Liquid Filled
FDA Label NDC 0031-8743

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Long-acting Coughgels (NDC 0031-8743). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, ask a doctor before use if you have, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.