ROBITUSSIN PEAK COLD COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution 
ROBITUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution 
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 Cough+Chest Congestion DM
Robitussin® Peak Cold Sugar-Free Cough+Chest Congestion DM
(dextromethorphan HBr, guaifenesin)

Drug Facts

Active ingredients
(in each 10 ml)		Purposes
Dextromethorphan HBr, USP 20 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if 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

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • this adult product is not intended for use in children under 12 years of age
agedose
adults and children 12 years and over10 ml every 4 hours
children under 12 yearsdo not use

Other information

Robitussin Peak Cold Cough+Chest Congestion DM

  • each 10 ml contains: sodium 7 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Robitussin Peak Cold Sugar-Free Cough+Chest Congestion DM

  • each 10 ml contains: sodium 5 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
  • alcohol-free

Inactive ingredients

Robitussin Peak Cold Cough+Chest Congestion DM

anhydrous citric acid, FD&C red no. 40, glycerin, high fructose corn syrup, menthol, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Robitussin Peak Cold Sugar-Free Cough+Chest Congestion DM

acesulfame potassium, artificial & natural flavor, citric acid monohydrate, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

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

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

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

ADULT

Robitussin®

PEAK COLD

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

Relieves:

✓
Cough
✓
Mucus

Non-Drowsy DM

For Ages 12 & Over

4 FL OZ
(118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

PRINCIPAL DISPLAY PANEL - 118 ml Sugar-Free Bottle Carton

ADULT

Robitussin®

PEAK COLD

SUGAR-FREE

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

Relieves:

✓
Cough
✓
Mucus

Specially
Formulated
for DIABETICS

Non-Drowsy DM
SUGAR-FREE
DYE-FREE

For Ages 12 & Over

4 FL OZ
(118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Sugar-Free Bottle Carton
ROBITUSSIN PEAK COLD COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8736
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) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorRED (clear red liquid) Score    
ShapeSize
FlavorPINEAPPLE (pineapple orange flavor and odor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8736-121 in 1 CARTON06/15/201103/31/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-8736-181 in 1 CARTON06/15/201103/31/2020
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0031-8736-421 in 1 CARTON06/15/201107/31/2019
3355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/15/201103/31/2020
ROBITUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8737
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) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (clear colorless to slightly yellow liquid) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8737-121 in 1 CARTON06/15/201108/31/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-8737-131 in 1 CARTON06/15/201101/31/2019
2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/15/201108/31/2020
Labeler - Richmond Division of Wyeth (829390835)

Revised: 1/2019
Document Id: dff8843a-fbc6-4c9f-9122-25e35dbbda87
Set id: 5b99dd81-8121-0fc4-1682-a3d1c0668859
Version: 7
Effective Time: 20190131
 
Richmond Division of Wyeth