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Tussin Peak Cold sugar-free COUGH PLUS CHEST CONGESTION DM

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 10mL, GUAIFENESIN 200mg in 10mL
Labeler: DISCOUNT DRUG MART
NDC Code: 53943-023

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 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: Discount Drug  Mart
211 Commerce Drive
Medina, OH 44256
www.discount-drugmart.com

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

DISCOUNT
drug
mart
FOOD FAIR

NDC 53943-023-20

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               Use Dosage
Mucus               Cup Included

Specially
Formulated
for DIABETICS

DM
SUGAR-FREE
DYE-FREE

Non-Drowsy                                       8 FL OZ
For Ages 12 & Over                           (237 mL)

TUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-023
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
CHERRY 
VANILLA 
GLYCERIN 
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) 
LEVOMENTHOL 
METHYLPARABEN 
POLYETHYLENE GLYCOL 400 
POVIDONE K30 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
Product Characteristics
ColorYELLOW (A clear colorless to slightly yellow) Score    
ShapeSize
FlavorCHERRY, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53943-023-201 BOTTLE in 1 CARTON
1237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/21/2015
Labeler - DISCOUNT DRUG MART (047741335)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(53943-023)

Revised: 04/2015
 
DISCOUNT DRUG MART

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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