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Tussin DM: Package Insert / Prescribing Info

Package insert / product label
Generic name: dextromethorphan hydrobromide and guaifenesin
Dosage form: oral liquid
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Active ingredients

Drug Facts

Active ingredients (in each 5 mL tsp)


Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Cough Suppressant
Expectorant

Keep out of reach of children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage for Tussin DM

  • 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

  • in a child under 12 years of age
  • 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.

Tussin DM Dosage and Administration

  • do not take more than 6 doses in any 24-hour period

Other information

  • Keep carton for full Directions for use.
  • store at 20‐25 ° C (68‐77 ° F)
  • do not refrigerate
  • dosage cup provided
  • sodium 3 mg per teaspoonful

Inactive ingredients

anhydrous citric acid, dextrose, FD and C red no.40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

NDC 68016-018-04

*COMPARE TO THE ACTIVE INGREDIENTS IN ROBITUSSIN® PEAK COLD COUGH and CHEST CONGESTION DM


Premier Value®

Tussin DM

Dextromethorphan HBr
Guaifenesin

COUGH SUPPRESSANT /
EXPECTORANT

Helps to Loosen
Chest Congestion

NON-DROWSY

Cough Formula
for ages 12 and over


4 FL OZ (118 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refundd.
*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold.

DISTRIBUTED BY:
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

BX-003

AptaPharmaPV TussinDM3 Label

res

TUSSIN DM COUGH SUPPRESSANT/EXPECTORANT
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-018
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
Product Characteristics
Color Score
ShapeSize
FlavorCHERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-018-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(68016-018)
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