Dolgencorp, LLC DM Cough & Congestion Relief Drug Facts

Dolgencorp, LLC DM Cough & Congestion Relief Drug Facts

Drug Labeling and Warnings

Drug Details

k">

REXALL DM COUGH AND CONGESTION RELIEF- dextromethorphan hbr, guaifenesin solution 
Dolgencorp Inc

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.

----------

Dolgencorp, LLC DM Cough & Congestion Relief Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 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 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Directions

  • shake well before using
  • 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

  • each 10 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F)

    Do not refrigerate.

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Package/Label Principal Display Panel

Adult

NON-DROWSY

MAXIMUM STRENGTH

DM Cough & Congestion Relief

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

GLUTEN FREE

Control cough

Relieves mucus & chest congestion

Alcohol free

Ages 12 & Over

4 FL OZ (118mL)

Rexall DM Cough & Congestion Relief Image 1
Rexall DM Cough & Congestion Relief Image 2
REXALL DM COUGH AND CONGESTION RELIEF 
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55910-799
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorRED (Opaque) Score    
ShapeSize
FlavorCHERRY (Menthol) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55910-799-261 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/10/2012
Labeler - Dolgencorp Inc (068331990)

Revised: 9/2015
 
Dolgencorp Inc


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.