Label: SUDOGEST- pseudoephedrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66336-096-20, 66336-096-30 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5125
- 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 September 14, 2011
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- Official Label (Printer Friendly)
- Active ingredient
- 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 drug 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
- Directions
- Other information
- Inactive ingredients
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Principal display panel
NDC 66336-0096-XX
NDC 66336-0096-20
NDC 66336-0096-30
SudoGest™
NASAL DECONGESTANT 60 mg
Pseudoephedrine Hydrochloride 60 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 Rev. 0807L11302
Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Rev. 10/10 Re-order No. 700324
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INGREDIENTS AND APPEARANCE
SUDOGEST
pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66336-096(NDC:0904-5125) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 44;113 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66336-096-20 20 in 1 BOTTLE, PLASTIC 2 NDC:66336-096-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/1994 Labeler - Dispensing Solutions, Inc. (066070785) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel, repack