FDA Label for Maximum Strength Nasal Decongestant
View Indications, Usage & Precautions
Maximum Strength Nasal Decongestant Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient (In Each Tablet)
Phenylephrine Hydrochloride 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
Otc - Do Not Use
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.
Otc - Ask Doctor
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
Otc - Stop Use
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 & children12 years & 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 20-25°C (68-77°F)
Inactive Ingredients
Carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrytalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, *contains one or more of these ingredients
Questions Or Comments?
1-888-333-9792
Other
Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Made in India
* Please review the disclaimer below.