TUSSIN SUGAR FREE COUGH  - dextromethorphan hydrobromide, guaifenesin liquid 
Atlantic Biologicals Corps

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

Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg

Purpose

Dextromethorphan HBr...................Cough suppressant Guaifenesin, USP..............................Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


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

• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema


When using this product

• do not use more than directed

Stop use and ask a doctor if

• 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 this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

• do not exceed 6 doses in a 24-hour period • this adult product is not intended for use in children under 12 years of age

                                                                adults and children 12 years and over     2 teaspoonfuls (tsps) every 4 hours children under 12 years                              do not use AgeDose


Other Information

sugar-free dosage cup provided

• store at controlled room temperature

alcohol-free




Inactive Ingredients

acesulfame potassium, citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate


TUSSIN SUGAR FREE COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID

Label Image
TUSSIN SUGAR FREE COUGH  
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5180(NDC:0904-5180)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
polyethylene glycol (UNII: 3WJQ0SDW1A)  
povidone (UNII: FZ989GH94E)  
propylene glycol (UNII: 6DC9Q167V3)  
saccharin sodium (UNII: SB8ZUX40TY)  
sodium benzoate (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-5180-110 mL in 1 CUP
2NDC:17856-5180-25 mL in 1 CUP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/07/2009
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL, REPACK

Revised: 11/2009
Document Id: 12eab105-e605-4010-8be9-850f593ac064
Set id: c1288446-789a-447c-b9ef-61d4a5427b9d
Version: 2
Effective Time: 20091114
 
Atlantic Biologicals Corps