Otis Clapp Mygrex
FDA Label NDC 47682-148

19 label sections · Submitted to the FDA by Unifirst First Aid Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Otis Clapp Mygrex (NDC 47682-148). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Otc - Purpose

Purpose

Pain reliever/fever reducer

Nasal decongestant

Indications & Usage

Uses

temporarily relieves these common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure

    • temporarily reduces fever

Warnings

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.

Otc - Do Not Use

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.
  • 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.
  • for more than 10 days for pain unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Otc - Stop Use

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms appear

      • These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions

  • do not use more than directed

    • Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

    Children under 12 years: Ask adoctor

Other Safety Information

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 Ingredient

Inactive ingredients corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch*, 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

250 Tablets
(125 x 2)
Medi-First ®
Sinus Pain and Pressure

Alivio al dolor y presion en los

senos nasales

Pull to Open
Tire Para Abrir

Aches & Fever • Acetaminophen 500 mg

Dolores, Fiebre • Acetaminofeno 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Descongestivo nasal • Hidrocloruro de fenilefrina 5 mg

This Package is For Households Without Young Children.

Este Paquete Es Para Hogares Sin Ninos Pequenos.

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Rvidente en Dosis Unitarias

Otis Clapp Mygrex Label

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.