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ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8741

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ROBITUSSIN® LINGERING COLD LONG-ACTING COUGHGELS

Drug Facts

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

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

Warnings

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

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.

If pregnant or breast-feeding, ask a health professional before use.

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 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

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

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

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton

ADULT
Robitussin®
LINGERING COLD

Long-Acting
CoughGels®

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:
Cough
for up to
8 Hours

Non-Narcotic
Formula

Non-Drowsy

For Ages 12
& Over

20
LIQUI-GELS®*
*Liquid-Filled Capsules

ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS 
dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8741
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MEDIUM-CHAIN TRIGLYCERIDES 
GELATIN 
GLYCERIN 
MANNITOL 
POLYETHYLENE GLYCOL 400 
POVIDONE K12 
PROPYL GALLATE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorRED (clear red) Scoreno score
ShapeOVAL (oval softgel) Size10mm
FlavorImprint CodeR
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8741-201 BOTTLE in 1 BLISTER PACK
120 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/06/2011
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIOperations
Pfizer Canada Inc.206472008ANALYSIS(0031-8741), LABEL(0031-8741), PACK(0031-8741)

Revised: 05/2012
 
Richmond Division of Wyeth

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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