Your browser does not support JavaScript! ULTRA TUSS DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]
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ULTRA TUSS DM (guaifenesin dextromethorphan hbr) syrup
[Ultra Seal Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

ctive Ingredients (In 5 ml) Guaifenesin   100 mg Dextromethorphann HBr 10 mg …

Purpose: Expectorant, Antitussive (Anti Cough)


Uses: temporarily:
•    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus,drain bronchial tubes, and make coughs more productive.
•    restores free breathing
•    suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants


Warnings:
•    A persistent cough may be a sign of a serious condition.  If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do not:
•    Use more than the recommended dose.
•    Give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.
•    Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.
•    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 MAOI drug. If you do not know if your prescription 
drug contains an MAOI, consult a doctor or pharmacist before 
taking this product
Stop use and ask a doctor if:
•    symptoms do not improve
•    new symptoms occur
•    redness or swelling is present
•    nervousness, dizziness or sleeplessness occur
•    symptoms do not improve within 7 days or are accompanied by 
fever
•    cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
Ask a doctor before use if you have:
•    heart disease
•    high blood pressure
•    thyroid disease
•    diabetes
•    difficulty in urination due to enlargement of the prostate gland
•    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

MM1



Ultra Tuss DM 16 oz label

Keep out of reach of children

Directions:
Adults and children 12 years of age and older
•    Take 2 teaspoons (10 ml) every 4 hours as needed, do not exceed 12 
teaspoons in 24 hours, or as directed by a doctor.
•    Children 6-12 years, Take 1 teaspoon ( 5 ml) every 4 hours as needed, do not exceed 6 teaspoons in 24 hours, or as directed by a doctor.
•    Children 2-6 years, Take 1/2 teaspoon ( 2.5 ml) every 4 hours as needed, do not exceed 3 teaspoons in 24 hours, or as directed by a doctor.
•    Children under 2 years, consult a physician

Inactive Ingredients: Citric Acid, FDC Red 40, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified water, Sodium Citrate, Sodium Saccharin

ULTRA TUSS DM 
guaifenesin dextromethorphan hbr syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42213-161
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
FD&C RED NO. 40  
SODIUM CITRATE 
SACCHARIN SODIUM ANHYDROUS 
PROPYLPARABEN 
METHYLPARABEN 
POTASSIUM SORBATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (sweet cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42213-161-93474 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/19/2012
Labeler - Ultra Seal Corporation (085752004)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture

Revised: 6/2012
 
Ultra Seal Corporation

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