AUROTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM - dextromethorphan hbr, guaifenesin liquid 
Aurohealth LLC

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.

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Drug Facts

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
  • 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: sodium 6 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • alcohol-free

Inactive ingredients

acesulfame potassium, anhydrous citric acid, flavors, glycerin, hydroxyethyl cellulose, menthol, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate


Questions or comments

1-855-274-4122

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237 mL Bottle)

AUROHEALTH

NDC 58602-118-24

Compare to the active ingredients in
Adult Robitussin
® Peak Cold
Sugar-Free Cough + Chest
Congestion DM*

ADULT
Tussin
PEAK COLD

Sugar-Free 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

For Ages 12 & Over

Specially
Formulated
for DIABETICS

DM
SUGAR-FREE
DYE-FREE

Cherry Flavor
Non-Drowsy                                       4 FL OZ (118 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 ML BOTTLE)

AUROTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-118
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CHERRY (UNII: BUC5I9595W)  
VANILLA (UNII: Q74T35078H)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorYELLOW (A clear colorless to slightly yellow) Score    
ShapeSize
FlavorCHERRY, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-118-241 in 1 CARTON04/21/201505/01/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-118-201 in 1 CARTON04/21/201505/01/2022
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-118-161 in 1 CARTON04/21/201505/01/2022
3355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/21/201505/01/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-118)

Revised: 11/2020
 
Aurohealth LLC