Aurotussin peak cold cough plus chest congestion dm liquid

Active ingredients (in each 10 ml)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 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

  • do not take more than 6 doses (12 tsp) in any 24-hour period
  • keep dosing cup with product
  • measure only with dosing cup provided
  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter

Age
Dose
adults and children 12 years
and over
10 mL
every 4 hours
children under 12 years
do not use

Other information

  • each 10 mL contains:sodium 6 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 red #40, flavors, glycerin, high fructose corn syrup,menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

Questions or comments

1-855-274-4122

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

Ingredients and appearance - Product information

Aurotussin peak cold cough plus chest congestion dm liquid- Dextromethorphan hbr, guaifenesin

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-115
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 10 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 mgin 10 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Orange ( UNII: 5EVU04N5QU)
Pineapple ( UNII: 2A88ZO081O)
Glycerin ( UNII: PDC6A3C0OX)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Menthol, unspecified form ( UNII: L7T10EIP3A)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sucralose ( UNII: 96K6UQ3ZD4)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color RED (a clear red colored liquid) Flavor PINEAPPLE

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( 58602-115)

Package label-principal display panel - 8 fl oz (236 ml bottle)

AUROHEALTH

NDC 58602-115-20

Compare to the active ingredients in
Adult Robitussin
® Peak ColdCough +
Chest Congestion DM*

ADULT

Aurotussin
PEAK COLD

Cough + Chest
Congestion DM

Each 10 mL dose of oral solution contains:
20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
200 mg - Guaifenesin, USP(Expectorant)

Relieves:

Cough
Mucus
Non-Drowsy DM

Pineapple Flavor 8 FL OZ
For Ages 12 & Over (236 mL)