FDA Label for Nasal And Sinus Decongestant
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)........................................................ PURPOSE
- USES:
- DO NOT USE:
- STOP USE AND ASK A DOCTOR IF
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- IF PREGNANT OR BREAST-FEEDING A BABY,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Nasal And Sinus Decongestant Product Label
The following document was submitted to the FDA by the labeler of this product Redicare 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.
Active Ingredient (In Each Tablet)........................................................ Purpose
Phenylephrine HCI 5 mg.......................................................................................................Decongestant
Uses:
Temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus opening and passages ■ restores free breathing
Do Not Use:
■ more than recommended dose ■ 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 MAOI drug. If you do not know if your prescription drug contains a MAOI, consult a doctor or pharmacist before taking this product.
Stop Use And Ask A Doctor If
■ symptoms do not improve ■ new symptoms occur ■ redness or swelling is present ■ nervousness, dizziness or sleeplessness occur ■ symptoms do not improve within 7 days or are accompanied by fever
Ask A Doctor Before Use If You Have:
■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland
If Pregnant Or Breast-Feeding A Baby,
ask a health professional before use.
Keep Out Of Reach Of Children.
In a case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions:
Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: consult a doctor
Other Information:
■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity
Inactive Ingredients:
corsscarmellose sodium, D&C Red #28, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid
Package Label.Principal Display Panel
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