ULTRA TUSS- guaifenesin syrup 
Ultra Seal Corporation

----------

Drug Facts

Active Ingredients (In 5 ml) Guaifenesin   100 mg

Purpose: Expectorant


Uses:temporarily:

• helps loosen phlegm (mucus)

• thin bronchial secretions to 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.

Stop use and ask a doctor if:

• symptoms do not improve

• new symptoms occur

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 health proffessional before use.

KEEP OUT OF REACH OF CHILDEREN.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 childern even if you do not notice any signs or smptoms.

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, FD& C Red 40, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Purified water, Sodium Citrate, Sodium Saccharin

Ultra Tuss 16 oz label

ULTRA TUSS 
guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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; Type 0: Not a Combination Product06/19/201204/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/19/201204/01/2022
Labeler - Ultra Seal Corporation (085752004)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(42213-160)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(42213-160)

Revised: 12/2023
 
Ultra Seal Corporation