Your browser does not support JavaScript! ULTRA TUSS (GUAIFENESIN ) SYRUP [ULTRA SEAL CORPORATION]
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ULTRA TUSS (guaifenesin ) 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

Purpose: Expectorant


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.


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.
•    Do not take his product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
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
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 16oz 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, Purified water, Sodium Citrate, Sodium Saccharin

ULTRA TUSS  
guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42213-160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
SODIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
METHYLPARABEN 
SACCHARIN 
Product Characteristics
Colorred (cherry red) Score    
ShapeSize
FlavorCHERRY (sweet cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42213-160-93474 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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