COUGH CONTROL DM MAX- dextromethorphan hbr, guaifenesin liquid 
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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, USP 10 mg

Guaifenesin, USP 200 mg

Purpose

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

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 this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • shake well before using 
  • do not exceed 6 doses in a 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • tsp = teaspoon, mL = milliliter
agedose 
 adults and children 12 years and over 2 teaspoonfuls (10 mL) every 4 hours 
 children under 12 years do not use 

Other information

  • each teaspoon contains: sodium 5 mg 
  • store at room temperature
  • alcohol-free
  • dosage cup provided

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, red 33, red 40, saccharin sodium, sodium benzoate, sorbitol, xanthan gum

Principal Display Panel

COUGH CONTROL DM MAX

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)

Maximum Strength for MUCUS RELIEF

NON-DROWSY

  • Controls Coughs
  • Relieves Mucus/Chest Congestion

ALCOHOL-FREE

For Adults

*Compare to the active ingredients in Robitussin® DM Max

SEE NEW DOSING INFORMATION

FL OZ (mL)

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributors of Robitussin® DM Max.

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

Distributed by: SELECT BRAND DISTRIBUTORS

Pine Bluff, AR 71603  USA  AC (870) 535-3635

MADE IN THE USA

Package Label

Dextromethorphan HBr 10 mg, Guaifenesin 200 mg

Select Brand Cough Control DM Max Liquid

COUGH CONTROL DM MAX 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-864
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) GUAIFENESIN200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-864-041 in 1 BOX09/08/201012/31/2020
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:15127-864-081 in 1 BOX09/08/201012/31/2020
2236 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 FINALpart34109/08/201012/31/2020
Labeler - Select Brand Dist. (012578514)

Revised: 8/2019
Document Id: ea92cdb6-f4a6-4b94-a3ba-f1aeea6738ff
Set id: e8663251-c645-49a9-a243-fc77072044a8
Version: 2
Effective Time: 20190809
 
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