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Drug Facts
Drug Facts (continued)
Assured Maximum Strength Nasal Decongestant
FDA Label NDC 68210-0118
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Assured Maximum Strength Nasal Decongestant (NDC 68210-0118). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Uses
■ temporarily relieves sinus congestion and pressure
■ temporarily relieves nasal congestion due to the common cold, hay
fever or other upper respiratory allergies
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
Otc - When Using
When using this product do not exceed recommended dose
Stop Use And Ask A Doctor If
■ nervousness, dizziness, or sleeplessness occur
■ symptoms do not improve within 7 days or occur with a fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away. (1-800-222-1222)
Directions
| 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 |
Other Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
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
Otc - Questions
Questions or comments? 1-888-333-9792
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-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
* Please review the disclaimer below.
