ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl 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 Peak Cold Maximum Strength Multi-Symptom Cold
(dextromethorphan HBr, guaifenesin, and phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Cough suppressant

Expectorant

Nasal decongestant

USES

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion
    • cough due to minor throat and bronchial irritation

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

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

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

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

  • shake well before using
  • do not take more than 6 doses 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 over2 teaspoons every 4 hours
children under 12 yearsdo not use

OTHER INFORMATION

  • each teaspoon contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose , xanthan gum

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.

Formerly CF Max

ADULT

Robitussin PEAK COLD MAXIMUM STRENGTH Multi-Symptom Cold

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

  • Nasal Congestion
  • Cough
  • Mucus

Non-Drowsy

For Ages 12 & Over

8 FL OZ (237 ml)

Find the right product for you with the Robitussin Relief Finder on Robitussin.com

  • at home
  • on your mobile phone

Use dosage cup included

Pfizer, Madison, NJ 07940 USA

© 2011 Pfizer Inc.

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

Droplet is not representative of actual product color.

Should be 18 or older to purchase

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

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

Maximum strength claim based on maximum daily dose of active ingredients.

Robitussin Peak Cold Maximum Strength Multi-Symptom Cold Packaging
ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8734
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorRED (translucent red) Score    
ShapeSize
FlavorPINEAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8734-121 in 1 CARTON06/15/201106/30/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-8734-181 in 1 CARTON06/15/201106/30/2017
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/15/201106/30/2017
Labeler - Richmond Division of Wyeth (829390835)

Revised: 2/2019
Document Id: 999c9340-9fcf-42cd-bb7c-581f926be602
Set id: 1b7e5948-97dc-a4ae-e545-2c8adb0e4003
Version: 4
Effective Time: 20190227
 
Richmond Division of Wyeth