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

Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM by

Drug Labeling and Warnings

Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM by is a Otc medication manufactured, distributed, or labeled by Richmond Division of Wyeth. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 ml)	Purposes
Dextromethorphan HBr, USP 20 mg	Cough suppressant
Guaifenesin, USP 200 mg	Expectorant

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

age	dose
adults and children 12 years and over	10 ml every 4 hours
children under 12 years	do 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

SPL UNCLASSIFIED SECTION

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 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)

INGREDIENTS AND APPEARANCE

ROBITUSSIN PEAK COLD COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8736
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED (clear red liquid)	Score
Shape		Size
Flavor	PINEAPPLE (pineapple orange flavor and odor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8736-12	1 in 1 CARTON	06/15/2011	03/31/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0031-8736-18	1 in 1 CARTON	06/15/2011	03/31/2020
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0031-8736-42	1 in 1 CARTON	06/15/2011	07/31/2019
3		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/15/2011	03/31/2020

ROBITUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8737
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (clear colorless to slightly yellow liquid)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8737-12	1 in 1 CARTON	06/15/2011	08/31/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0031-8737-13	1 in 1 CARTON	06/15/2011	01/31/2019
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/15/2011	08/31/2020

Labeler - Richmond Division of Wyeth (829390835)