NDC | 68210-0118-3 |
Set ID | 82d5d61d-8de5-4886-e053-2a91aa0ac831 |
Category | HUMAN OTC DRUG LABEL |
Packager | Spirit Pharmaceuticals LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- 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
- WHEN USING
- Stop use and ask a doctor if
- SPL UNCLASSIFIED SECTION
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
-
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:68210-0118 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 T234 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0118-3 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) Establishment Name Address ID/FEI Business Operations Time Cap Laboratories, Inc 037052099 manufacture(68210-0118)