Aurotussin peak cold multi-symptom cold liquid

Active ingredients (in each 10 ml)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Phenylephrine HCl, USP 10 mg

Purposes

Cough suppressant
Expectorant
Nasal decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with a cold:
nasal congestion
cough due to minor throat and bronchial irritation

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed

Stop use and ask a doctor if
you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
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
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

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:sodium6 mg
  • store at 20-25C (68-77F). Do not refrigerate

Inactive ingredients

anhydrous citric acid, FD&C Red No. 40 powder, glycerin, menthol, noncrystallizing sorbital solution, 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

Aurotussin peak cold multi-symptom cold liquid- Dextromethorphan hbr, guaifenesin, phenylephrine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-144
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
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 10 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Levomenthol ( UNII: BZ1R15MTK7)
Sorbitol ( UNII: 506T60A25R)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color RED (a clear red colored liquid) Flavor BERRY

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( 58602-144)

Package label-principal display panel -8 fl oz (237 ml bottle)

AUROHEALTH

NDC 58602-144-20

Compare to the active ingredients in
Adult Robitussin® Peak Cold Multi-Symptom Cold*

ADULT

Aurotussin
PEAK COLD
Multi-Symptom Cold

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

Relieves:

Cough
Nasal Congestion
Mucus

Berry Flavor
Non-Drowsy8 FL OZ
For Ages 12 & Over (237 mL)