TUSSIN DM SUGAR FREE NON DROWSY- dextromethorphan hbr, guaifenesin liquid 
QUALITY CHOICE (Chain Drug Marketing Association)

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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Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Purposes

Cough suppressant

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 make coughs more productive

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

When using this product,

do not use more than directed.

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 (1-800-222-1222) right away.

Directions

  • 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
  • measure only with dosing cup provided
  • keep dosing cup with product
  • tsp = teaspoon, mL = milliliter
  age  dose
  adults and children 12 years and over  2 tsp (10 mL) every 4 hours
  children under 12 years  do not use

Other information

  • store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive ingredients

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

Principal Display Panel

*Compare to the active ingredients in Robitussin® Peak Cold Sugar-Free Cough & Chest Congestion DM

Sugar-Free

Non-Drowsy

Tussin DM

Cough & Chest Congestion

Dextromethorphan HBr  Cough Suppressant

Guaifenesin  Expectorant

Relieves:

Cough

Mucus

For Ages 12 & Over

Alcohol Free

DM Sugar-Free Formula Specially Formulated for Diabetic Use

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Sugar-Free Cough & Chest Congestion DM.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Package Label

 Dextromethorphan HBr 10 mg, Guaifenesin 100 mg

Quality Choice Sugar-Free Non-Drowsy Tussin DM

TUSSIN DM  SUGAR FREE NON DROWSY
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-846
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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-846-521 in 1 BOX10/31/201412/30/2022
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/31/201412/30/2022
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 11/2020
Document Id: 81f41ce5-deb2-4425-926b-6cce72c8d66c
Set id: 2338c5c5-485f-415c-bb7d-b3d75dcb9137
Version: 4
Effective Time: 20201130
 
QUALITY CHOICE (Chain Drug Marketing Association)