Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

TUSSIN PEAK COLD MAXIMUM STRENGTH 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.

----------

Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 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

  • shake well before using
  •  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 8 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • alcohol-free
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

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 Container Label)

NDC: 58602-511-20

PrimaryHealth

COMPARE TO Adult Robitussin®
Peak Cold Maximim Strength Cough +
Chest Congestion DM active ingredients*

ADULT

Tussin
PEAK COLD
Maximum Strengh
Cough + Chest Congestion DM

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

Relieves:

Cough Mucus

DM
MAX
For Ages 12 & Over 
Cherry Flavor
Non-Drowsy 
8 FL OZ (237 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (237 mL Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237  mL Container Carton Label)

NDC: 58602-511-20

PrimaryHealth

COMPARE TO Adult Robitussin
®
Peak Cold Maximim Strengh Cough +
Chest Congestion DM active ingredients*

ADULT

Tussin
PEAK COLD
MAXIMUM STRENGTH
Cough + Chest
Congestion DM

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

Relieves:

Cough
Mucus

DM
MAX
For Ages 12 & Over

Cherry Flavor                              
Non-Drowsy
8 FL OZ (237 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237  mL Container Carton Label)

TUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-511
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) GUAIFENESIN400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CHERRY (UNII: BUC5I9595W)  
VANILLA (UNII: Q74T35078H)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorRED (a red colored liquid) Score    
ShapeSize
FlavorCHERRY, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-511-201 in 1 CARTON09/19/2018
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/19/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-511)

Revised: 9/2018
 
Aurohealth LLC


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.