CHILDRENS COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin solution

Childrens Cough and Chest Congestion DM by

Drug Labeling and Warnings

Childrens Cough and Chest Congestion DM by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 5 mL)

Dextromethorphan HBr, USP, 5mg

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 your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• 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.

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

• do not give more than 6 doses in a 24 hour period.
• give the recommended number of vials below, following the instructions under How to Open and Use on the side panel.
• empty all liquid in each Single-Use Vial when dosing.

• Age: Dose (mL)
• under 4 years: Do not use
• 4-6 years: 1 Single-Use Vial (5mL) Every 4 hours
• 6-12 years: 1-2 Single-Use Vial (5mL Each) Every 4 hours
• Adults and Children over 12 years: 2-4 Single-Use Vial (5mL Each) Every 4 hours

Inactive Ingredients

Citric Acid, Glycerin, Mixed Berry Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Saccharine, Sorbitol, Sucralose, Trisodium Citrate Dihydrate, Xanthan Gum.

Other Information

• each Single-Use Vial contains 8mg of sodium.
• store at 20-25 °C (68-77 °F).
• tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken.

Questions or Comments?

1-800-719-9260

Package Labeling:

INGREDIENTS AND APPEARANCE

CHILDRENS COUGH AND CHEST CONGESTION DM 
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-262
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-262-01	1 in 1 BOX	12/04/2018
1		100 mL in 1 VIAL; 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	12/04/2018

Labeler - CVS Pharmacy (062312574)