Childrens aurotussin cough and chest congestion dm liquid

Active ingredients (in each 5 ml)

Dextromethorphan HBr, USP5 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

  • each5 mL contains:sodium3 mg
  • store at 20-25C (68-77F). 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

Ingredients and appearance - Product information

Childrens aurotussin cough and chest congestion dm liquid- Dextromethorphan hbr, guaifenesin

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-153
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 5 mgin 5 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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 Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

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

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

GrapeFlavor
4FL OZ
(118 mL)