Label: SUDOGEST- pseudoephedrine hydrochloride tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 52959-260-00, 52959-260-20, 52959-260-24, 52959-260-25, view more52959-260-30, 52959-260-40, 52959-260-60 - Packager: H.J. Harkins Company, 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 January 19, 2012
If you are a consumer or patient please visit this version.
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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
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available
MAJOR®
FOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
NDC 0904-5125-59
SudoGest™
NASAL DECONGESTANT 60 mg
Pseudoephedrine Hydrochloride 60 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever
Without Drowsiness
100 TABLETS
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
Repacked by H.J. Harkins Company, Inc.
Nipomo, CA 93444
Rev. 10/11 Re-order No. 700324
Product Packaging
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INGREDIENTS AND APPEARANCE
SUDOGEST
pseudoephedrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-260(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:52959-260-00 100 in 1 BOTTLE, PLASTIC 2 NDC:52959-260-20 20 in 1 BOTTLE, PLASTIC 3 NDC:52959-260-24 24 in 1 BOTTLE, PLASTIC 4 NDC:52959-260-25 25 in 1 BOTTLE, PLASTIC 5 NDC:52959-260-30 30 in 1 BOTTLE, PLASTIC 6 NDC:52959-260-40 40 in 1 BOTTLE, PLASTIC 7 NDC:52959-260-60 60 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 - H.J. Harkins Company, Inc. (147681894) Registrant - H.J. Harkins Company, Inc. (147681894) Establishment Name Address ID/FEI Business Operations H.J. Harkins Company, Inc. 147681894 repack, relabel