NDC | 55301-453-23, 55301-453-44 |
Set ID | 7530eda5-3ad5-4ac8-9b80-181e1d7b7542 |
Category | HUMAN OTC DRUG LABEL |
Packager | ARMY AND AIR FORCE EXCHANGE SERVICE |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
exchange✓select™
SINUS
Compare To The Active Ingredient of Sudafed PE® Congestion*
SUPHEDRINE PE
CONGESTION
Phenylephrine HCl 10 mg, Nasal Decongestant• Maximum Strength
• Sinus Pressure
• CongestionNON-DROWSY
Actual Size
72 Tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Congestion.
50844 REV0118K45323"SATISFACTION GUARANTEED OR YOUR MONEY BACK"
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 11788
1-800-426-939144-453
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INGREDIENTS AND APPEARANCE
SUPHEDRINE PE CONGESTION NON-DROWSY
phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-453 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape ROUND Size 7mm Flavor Imprint Code 44;453 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-453-23 3 in 1 CARTON 01/14/2005 06/25/2023 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:55301-453-44 1 in 1 CARTON 01/14/2005 06/25/2023 2 18 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 01/14/2005 06/25/2023 Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(55301-453) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(55301-453) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(55301-453) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(55301-453) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(55301-453)