FDA Label for Medi First Plus Sinus Pain And Pressure

View Indications, Usage & Precautions

Medi First Plus Sinus Pain And Pressure Product Label

The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. 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 Ingredients (In Each Tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

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

Allergy Alert:

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.

Do Not Use

■ 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.

Ask A Doctor Before Use If You Have

■ liver disease

■ thyroid disease

■ diabetes

■ high blood pressure

■ heart disease

■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

■ 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

Do Not Exceed Recommended Dosage.

If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

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.

Other Information

■ 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

Inactive Ingredients

corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate*, stearic acid.

*may contain

Otc - Questions

Questions or comments? 1-800-634-7680

Medi-First Plus Sinus Pain And Pressure Label

100 Tablets
(50 x 2's)
Medi First ^® Plus
Sinus Pain and Pressure
Aches & Fever • Acetaminophen 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children

Sinus Pain Releif

Tamper Evident

Unit Dose Packets

Medi-First Sinus Pain And Pressure Label

50Tablets
(25 x 2)
Medi-First ^®
Sinus Pain and Pressure