CHILDRENS AUROTUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin liquid

Childrens Aurotussin Cough and Chest Congestion DM by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 5 mL)

Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 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 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 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

measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
do not take more than 6 doses in any 24-hour period

• Age: Dose
• children under 6 years: do not use
• children 6 to under12 years: 5 to 10 mL every 4 hours
• adults and children12 years and over: 10 to 20 mL every 4 hours

Other information

• each 5 mL contains: sodium 3 mg
• store at 20-25°C (68-77°F). Do not refrigerate
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, FD&C blue#1, FD&C red 40 powder, flavor, glycerin, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions or Comments

1-855-274-4122

Distributed by: Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -4 FL OZ (118 mL Bottle)

AUROHEALTH

NDC: 58602-153-24
Compare to the active ingredients in
Children's Robitussin® Cough
& Chest Congestion DM*

Ages 6 & Over
Children's
Aurotussin
Cough & Chest
Congestion DM

Each 5 mL dose of oral solution contains:
5 mg - Dextromethorphan HBr, USP (Cough Suppressant) 100 mg - Guaifenesin, USP (Expectorant)
Relieves:

• Chest Congestion/Mucus
• Cough

Alcohol free
Non-Drowsy

Grape Flavor                        4 FL OZ
                                             (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS AUROTUSSIN COUGH AND CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-153
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GRAPE (UNII: 6X543N684K)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-153-24	1 in 1 CARTON	06/30/2015
1		118 mL in 1 BOTTLE; 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	06/30/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-153)