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Childrens Aurotussin Cough and Chest Congestion DM

Medically reviewed on June 22, 2017.

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Aurohealth LLC
NDC Code: 58602-153

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.

Drug Facts

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 under
12 years
5 to 10 mL every 4 hours
adults and children
12 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)




CHILDRENS AUROTUSSIN COUGH AND CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-153
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GRAPE 
GLYCERIN 
SORBITOL 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-153-241 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-153)

 
Aurohealth LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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