Label: RUGBY NASAL DECONGESTANT NASAL DECONGESTANT- pseudoephedrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68258-8000-4 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0536-1850
- 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 October 6, 2011
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each teaspoonful [TSP])
- Purpose
- Uses
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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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RUGBY NASAL DECONGESTANT NASAL DECONGESTANT
pseudoephedrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-8000(NDC:0536-1850) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Citric Acid Monohydrate (UNII: 2968PHW8QP) Methylparaben (UNII: A2I8C7HI9T) FD&C Red no. 40 (UNII: WZB9127XOA) Glycerin (UNII: PDC6A3C0OX) Raspberry (UNII: 4N14V5R27W) Water (UNII: 059QF0KO0R) Sodium Benzoate (UNII: OJ245FE5EU) Saccharin Sodium (UNII: SB8ZUX40TY) Product Characteristics Color red Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68258-8000-4 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/26/1999 Labeler - Dispensing Solutions, Inc. (066070785) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel, repack