Active Ingredients And Purpose
Active ingredient (in each tablet)
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Phenylephrine HCl 10 mg
Nasal decongestant
■ temporarily relieves sinus congestion and pressure ■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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.
■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland
■ nervousness, dizziness, or sleeplessness occur ■ symptoms do not improve within 7 days or occur with a fever
adults and children 12 years and over ■ take 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours children under 12 years ask a doctor
croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Questions or comments? 1-888-333-9792
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-Drowsy Actual Size PSEUDOEPHEDRINE FREE 24tablets †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Drug Facts
Phenylephrine HCl 10 mg
Nasal decongestant
■ temporarily relieves sinus congestion and pressure ■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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.
■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland
When using this product do not exceed recommended dose
■ nervousness, dizziness, or sleeplessness occur ■ symptoms do not improve within 7 days or occur with a fever
Drug Facts (continued)
adults and children 12 years and over ■ take 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours children under 12 years ask a doctor
store between 20° to 25°C (68° to 77°F)
croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Questions or comments? 1-888-333-9792
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-Drowsy Actual Size PSEUDOEPHEDRINE FREE 24tablets †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion
Official SPL XML cached by FDA.report · DailyMed PDF
| Folder | File | Date |
|---|---|---|
| otc | d2045850-898c-ec0f-e053-2a95a90ae737.xml | 2021-12-01 |
| otc | b5e7bf75-6986-a212-e053-2a95a90ae166.xml | 2020-12-09 |
| otc | 9af040f2-f7ad-2b36-e053-2995a90af70a.xml | 2019-12-31 |
| otc | 9aa38918-34ed-1b8f-e053-2a95a90ad14d.xml | 2019-12-27 |
| otc | 82d60239-4861-7a7a-e053-2991aa0ab42a.xml | 2019-02-27 |
| otc | Assured Nasal Decongestant 24 tablets.jpg | 2019-02-27 |