Label: ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT- phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-1180-2 - Packager: Spirit Pharmaceuticals LLC
- 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 November 30, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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 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
- WHEN USING
- Stop use and ask a doctor if
- SPL UNCLASSIFIED SECTION
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
ASSURED
COMPARE TO ACTIVE INGREDIENT IN
SUDAFED® PE CONGESTION®†MAXIMUM STRENGTH
Nasal Decongestant
· Phenylephrine HCl 10 mg - Nasal Decongestant
Relieves Nasal & Sinus Congestion,
Reduces Sinus Pressure, Non-DrowsyActual Size
PSEUDOEPHEDRINE FREE
24tablets
†This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Sudafed PE® Congestion -
INGREDIENTS AND APPEARANCE
ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT
phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1180 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) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape CAPSULE Size 8mm Flavor Imprint Code 272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-1180-2 1 in 1 CARTON 02/26/2019 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 02/26/2019 Labeler - Spirit Pharmaceuticals LLC (179621011) Registrant - Spirit Pharmaceuticals LLC (179621011) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 manufacture(68210-1180)