ULTRA TUSS SAFE- guaifenesin dextromethorphan hbr syrup 
Ultra Seal Corporation

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Drug Facts

Active Ingredients (In 5 ml)

Guaifenesin   100 mg

Dextromethorphann HBr 10 mg

Purpose:Expectorant, Antitussive (Anti Cough)

Uses:temporarily:

• helps loosen phlegm (mucus)

• thin bronchial secretions to 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:

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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

• more than the recommended dose.

Stop use and ask a doctor if:

• 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. These could be signs of a serious condition.

Ask a doctor before use if you have:

• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

If pregnant or breast-feeding,ask a healthprofessional before use.

KEEP OUT OF REACH OF CHILDREN.In case of overdose, get medical help or contact a Poison Control Center Right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Do not exceed 6 doses in any 24 hour period.

Adults and children 12 years of age and older: Take 2 teaspoons (10 ml) every 4 hours as needed, or as directed by a doctor.

Children 6-12 years: Take 1 teaspoon ( 5 ml) every 4 hours as needed, or as directed by a doctor.

Not to be used for children under 6 years of age.

Inactive Ingredients:Citric Acid, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose

ultra tuss safe 4 oz box

ULTRA TUSS SAFE 
guaifenesin dextromethorphan hbr syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-162
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (sweet cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42213-162-831 in 1 CARTON06/19/2012
1NDC:42213-162-86119 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/19/201209/01/2023
Labeler - Ultra Seal Corporation (085752004)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(42213-162)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(42213-162)

Revised: 12/2023
 
Ultra Seal Corporation