Active Ingredients (In Each Tablet)
Acetaminophen 500mg
Phenylephrine HCl 5mg
The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medi First Plus Sinus Pain And Pressure (NDC 47682-919). 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 active ingredients (in each tablet), purpose, uses, warnings, other, allergy alert:, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500mg
Phenylephrine HCl 5mg
Pain reliever/fever reducer
Nasal decongestant
Temporarily relieves nasal congestion due to
■ common cold
■ hay fever or other respiratory allergies
Temporarily
■ promotes nasal and/or sinus drainage; relieves sinus congestion and pressure
■ reduces fever
Temporarily relieves minor aches and pains associated with
■ headache
■ muscular aches
■ minor arthritis pain
■ common cold
■ toothache
■ menstrual cramps
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Adults and children: (12 years and older) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ for more than 10 days for pain unless directed by a doctor
■ for more than 3 days for fever unless directed by a doctor
■ 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.
■ liver disease
■ thyroid disease
■ diabetes
■ high blood pressure
■ heart disease
■ difficulty in urination due to enlargement of the prostate gland
■ taking the blood thinning drug warfarin
■ symptoms do not improve within 7 days or are accompanied by a fever
■ pain or fever persists or gets worse
■ redness or swelling is present
■ any new symptoms appear
If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.
ask a health professional before use.
In 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
■ do not use more than directed
■ store at room temperature 59°-86°F (15°-30°C)
■ tamper evident sealed packets
■ do not use any opened or torn packets
■ avoid excessive heat and humidity
corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate*, stearic acid.
*may contain
1-800-634-7680
100 Tablets
(505 x 2's)
Medi First ® Plus
Sinus Pain and Pressure
Aches & Fever • Acetaminophen 500mg
Nasal Decongestant • Phenylephrine HCl 5 mg
Pull to Open
This Package is For Households Without Young Children
Sinus Pain Relief
Tamper Evident
Unit Dose Packet
50 Tablets
(20 x 2)
Medi-First ®
Sinus Pain and Pressure
Sinus Pain Relief
Pull to Open
Aches & Fever • Acetaminophen 500 mg
Nasal Decongestant • Phenylephrine HCl 5 mg
This Package is For Households Without Young Children
Tamper Evident
Unit Dose Packets
Otis Clapp
Quality and Integrity Since 1840
MYGREX ™
Pain Reliever-Decongestant
Advanced Relief
For Sinus/Headaches
See Warnings and Directions on Side Panel
This package is for Households without Young Children
Acetaminophen 500 mg • Aches & Fever
Phenylephrine HCl 5 mg • Nasal Decongestant
Tear Out Along Perforation To Dispense
PROFESSIONAL HEALTHCARE
300 Tablets (150 PACKETS OF 2)
* Please review the disclaimer below.