Label: MEDI-FIRST SINUS DECONGESTANT- phenylephrine hydrochloride tablet, film coated
MEDI-FIRST PLUS SINUS DECONGESTANT- phenylephrine hydrochloride tablet, film coated
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NDC Code(s):
47682-809-13,
47682-809-33,
47682-809-46,
47682-809-48, view more47682-809-64, 47682-990-33, 47682-990-48
- Packager: Unifirst First Aid Corporation
- 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 March 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- Medi-First Sinus Decongestant Label
- Medi-First Plus Sinus Decongestant Label
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INGREDIENTS AND APPEARANCE
MEDI-FIRST SINUS DECONGESTANT
phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-809 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red (red) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-809-64 24 in 1 BOX 12/30/2008 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-809-33 100 in 1 BOX 12/30/2008 2 1 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-809-48 250 in 1 BOX 12/30/2008 3 1 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:47682-809-13 500 in 1 BOX 12/30/2008 4 NDC:47682-809-46 1 in 1 PACKET; Type 0: Not a Combination Product 5 NDC:47682-809-46 1 in 1 PACKET; Type 0: Not a Combination Product 12/30/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2008 MEDI-FIRST PLUS SINUS DECONGESTANT
phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-990 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red (red) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-990-33 100 in 1 BOX 04/18/2019 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-990-48 250 in 1 BOX 04/18/2019 2 1 in 1 PACKET; 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 04/18/2019 Labeler - Unifirst First Aid Corporation (832947092)