ADULT TUSSIN CF MULTI-SYMPTOM COLD - dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Marc Glassman, Inc.

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
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: sodium 6 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • see bottom panel for lot number and expiration date 

Inactive ingredients

anhydrous citric acid, FD & C Red No. 40 powder, glycerin, menthol, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Distributed by:
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130

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

NDC 68998-528-20

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

Marcs®
adult
Tussin CF
MULTI-SYMPTOM COLD

Dextromethorphan HBr
(Cough Suppressant)
Guaifenesin
(Expectorant)
Phenylephrine HCl
(Nasal Decongestant)

For Relief of:

 

  • Cough
  • Nasal Congestion
  • Mucus
  • For Ages 12 & Over
  • Non-Drowsy                               
  • Berry Flavor

 

8 FL OZ (237 mL)   

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ADULT TUSSIN CF MULTI-SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-528
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorRED (a clear red colored liquid) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68998-528-201 in 1 CARTON07/14/201709/20/2020
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 FINALpart34107/14/201709/20/2020
Labeler - Marc Glassman, Inc. (094487477)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(68998-528)

Revised: 11/2020
 
Marc Glassman, Inc.