ROBITUSSIN NIGHT TIME COUGH AND COLD- diphenhydramine hydrochloride and phenylephrine hydrochloride  liquid 
Richmond Division of Wyeth

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.

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ROBITUSSIN NIGHT TIME COUGH & COLD
(diphenhydramine HCl and phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Diphenhydramine HCl , USP 6.25 mg

Phenylephrine HCl, USP 2.5 mg

PURPOSES

Antihistamine/Cough Suppressant

Nasal Decongestant

USES

WARNINGS

Do not use

  • to sedate a child or to make a child sleepy
  • 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.
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children.

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts 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

agedose
adults and children 12 years and over4 teaspoons every 4 hours
children under 12 yearsdo not use

OTHER INFORMATION

INACTIVE INGREDIENTS

anhydrous citric acid, artificial flavors, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

See New Dosing Information

Adult

Robitussin Night Time Cough & Cold

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHENYLEPHRINE HCl (Nasal Decongestant)

RELIEVES:

For Ages 12 & Over

Alcohol-Free

4 FL OZ (118 mL)

Robitussin Knows

Choosing the right product is important. Robitussin has different products for adults and for children.

GREEN Boxes

Ages 12 & Over

RED Boxes

Ages Under 12

Use as directed

DOSAGE CUP INCLUDED

Wyeth Consumer Healthcare

Madison, NJ 07940 U.S.A.

©2009 Wyeth

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

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Robitussin Night Time Cough & Cold Packaging
ROBITUSSIN NIGHT TIME COUGH AND COLD 
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0031-8698
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine hydrochloride (diphenhydramine ) diphenhydramine hydrochloride6.25 mg  in 5 mL
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 2.5 mg  in 5 mL
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8698-131 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0031-8698-191 in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/09/2006
Labeler - Richmond Division of Wyeth (829390827)

Revised: 6/2009
Document Id: e08eea30-66dd-7c00-2527-2cfd83821456
Set id: e08eea30-66dd-7c00-2527-2cfd83821456
Version: 1
Effective Time: 20090623
 
Richmond Division of Wyeth