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 New Vision Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each 5mL)

Dextromethorphan HBr, USP, 5mg

Guaifenesin, USP, 100mg

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 cough 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

persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

cough lasts for more than 7 days, tends to recur, 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 any 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

                                                                                    Dosing Chart

• Age (Years): Dose
• under 4 years: Consult a doctor
• 4 – 5 years: 1 Single-Use Vial (5 mL) every 4 hours
• 6 – 11 years: 1 – 2 Single-Use Vials (5 mL each) every 4 hours
• Adults and children 12 years and over: 2 – 4 Single-Use Vials (5 mL 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 6mg of sodium
• store at 20-25ºC (68-77ºF)
• 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?

+1-954-721-5000 Mon – Fri 9am to 6pm EST

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: 70302-013
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: 70302-013-20	20 in 1 BOX	11/01/2018
1		5 mL in 1 VIAL, SINGLE-USE; 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	11/01/2018

Labeler - Unipharma, LLC (079524332)

Establishment
Name	Address	ID/FEI	Business Operations
Unipharma, LLC		079524332	manufacture(70302-013)