Actifed Tablet
FDA Label NDC 27854-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Belmora Llc for the product Actifed (NDC 27854-119). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, 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 5mg
Purpose
Nasal decongestant
Uses
Temporarily relieves • nasal congestion due to the common cold, hay fever or other upper respiratory allergies • sinus congestion and pressure
Warnings
Do not use • If you are now taking a prescription monoamineoxidase 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.
When using this product do not exceed recommended dosage
Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever
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
• do not use more than directed
| Adults & Children: (12 years & older) | Take 2 tablets every 4-6 hours. Do not take more than 12 tablets in 24 hours. |
| Children under 12 years: | Ask a doctor |
Other Information
• store at room temperature 59°-86° F (15°-30° C).
• tamper evident sealed packets.
• do not use any opened or torn packets
Inactive Ingredients
croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide
Questions Or Comments?
Call 1-888-779-2877 M-F 9AM-5PM EST
Belmora LLC 3033 Wilson Blvd. Suite 700 Arlington, VA 22201
Packaging
Actifed-119 (2785411901)
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