Cough Control DM by Select Brand Dist. Drug Facts

Cough Control DM by

Drug Labeling and Warnings

Cough Control DM by is a Otc medication manufactured, distributed, or labeled by Select Brand Dist.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COUGH CONTROL DM SUGAR FREE- dextromethorphan hbr, guaifenesin liquid 
Select Brand Dist.

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 100 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 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 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

• age: dose
• adults and children 12 years and over: 2 teaspoonfuls (10 mL) every 4 hours
• children under 12 years: do not use

Other information

• alcohol-free
• sugar-free
• dosage cup provided 
• store at room temperature

Inactive ingredients

acesulfame potassium, citric acid, flavors, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

Principal Display Panel

COUGH CONTROL DM SUGAR FREE

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin) 

DIABETICS Formula

• Controls Coughs
• Loosens and Relieves Chest Congestion

ALCOHOL-FREE

For Adults

*Compare to the active ingredients in Robitussin® Cough Sugar Free DM

SEE NEW DOSING INFORMATION 

FL OZ (mL)

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

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

Select Brand Cough Control DM Sugar Free Liquid

COUGH CONTROL DM  SUGAR FREE
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-806
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-806-04	1 in 1 BOX	09/08/2010	12/31/2019
1		118 mL in 1 BOTTLE, PLASTIC; 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	09/08/2010	12/31/2019

Labeler - Select Brand Dist. (012578514)

Revised: 4/2019

Document Id: a5dce154-e0e4-4c7f-a0c6-1e09c391b5e4

34390-5

Set id: b464a54b-b4e1-4310-bd75-49f73c3a58a9

Version: 2

Effective Time: 20190415