Label: NASAL DECONGESTANT MAXIMUM STRENGTH- phenylephrine hcl tablet, film coated
- NDC Code(s): 68016-757-15, 68016-757-24
- Packager: Chain Drug Consortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 27, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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?
-
Principal Display Panel
Premier Value®
*COMPARE TO THE ACTIVE INGREDIENT IN
SUDAFED PE® SINUS CONGESTIONMaximum Strength
Nasal Decongestant PEPhenylephrine HCl 10 mg
NASAL DECONGESTANTRelief of:
• Sinus Pressure
• Sinus CongestionNon-drowsy
actual
size36 Tablets
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDTAMPER 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® SINUS
CONGESTION.
50844 REV0820A45307Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.44-453
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INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT MAXIMUM STRENGTH
phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-757 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, UNSPECIFIED (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:68016-757-24 1 in 1 CARTON 01/14/2005 1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:68016-757-15 2 in 1 CARTON 01/14/2005 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 Drug M012 01/14/2005 Labeler - Chain Drug Consortium (101668460) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(68016-757) , pack(68016-757) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(68016-757) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(68016-757) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(68016-757)