Label: SUDOGEST- pseudoephedrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-806-12 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0904-5053
- Category: HUMAN OTC DRUG LABEL
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 March 6, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredient (in each tablet)
- 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 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- diabetes
- thyroid disease
- heart disease
- high blood pressure
- trouble urinating due to enlargement of the prostate gland
- DOSAGE & ADMINISTRATION
- Keep out of the reach of children.
- Directions
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUDOGEST
pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-806(NDC:0904-5053) 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 Inactive Ingredients Ingredient Name Strength Croscarmellose Sodium (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) Magnesium Stearate (UNII: 70097M6I30) Polydextrose (UNII: VH2XOU12IE) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Titanium Dioxide (UNII: 15FIX9V2JP) Triacetin (UNII: XHX3C3X673) Product Characteristics Color RED Score no score Shape ROUND Size 7mm Flavor Imprint Code 44112 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-806-12 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/1994 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK