Label: SUDOGEST- pseudoephedrine hcl tablet, film coated
- NDC Code(s): 71205-133-24
- Packager: Proficient Rx LP
- 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 October 1, 2019
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- Official Label (Printer Friendly)
- 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 2 for 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
- •
- heart disease
- •
- diabetes
- •
- thyroid disease
- •
- high blood pressure
- •
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 7105-133-24
*Compare to the active ingredient in Sudafed® CongestionFOR PHARMACY USE ONLY.
NOT FOR RETAIL SALE.
Non-Drowsy
SudoGest™
NASAL DECONGESTANT
Pseudoephedrine Hydrochloride 30 mg
Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness24 TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
50844 REV0712L11212Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Rev. 08/13
Re-Order No. 700321Relabeled By;
Proficient Rx LP
Thousand Oaks CA 91320
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INGREDIENTS AND APPEARANCE
SUDOGEST
pseudoephedrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-133(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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C RED NO. 40 (UNII: WZB9127XOA) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color RED Score no score Shape ROUND Size 7mm Flavor Imprint Code 44;112 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-133-24 1 in 1 CARTON 10/01/2018 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/25/1981 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-133)