Label: TUSSIN SUGAR FREE COUGH- dextromethorphan hydrobromide, guaifenesin liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 17856-5180-1, 17856-5180-2 - Packager: Atlantic Biologicals Corps
- This is a repackaged label.
- Source NDC Code(s): 0904-5180
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 14, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
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
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep this and all drugs out of the reach of children.
- Directions
- Other Information
- Inactive Ingredients
- TUSSIN SUGAR FREE COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID
-
INGREDIENTS AND APPEARANCE
TUSSIN SUGAR FREE COUGH
dextromethorphan hydrobromide, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-5180(NDC:0904-5180) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor CHERRY (Cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-5180-1 10 mL in 1 CUP 2 NDC:17856-5180-2 5 mL in 1 CUP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/07/2009 Labeler - Atlantic Biologicals Corps (047437707) Registrant - Atlantic Biologicals Corps (047437707) Establishment Name Address ID/FEI Business Operations Atlantic Biologicals Corps 047437707 RELABEL, REPACK