Medique Medicidin D Tablet, Film Coated
FDA Label NDC 47682-120

Full FDA labeling including 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 Medique Medicidin D (NDC 47682-120). 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, active ingredients (in each tablet), purposes, temporarily relieves minor aches and pains associated with, temporarily relieves nasal congestion due to, temporarily, warnings, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.

Adults and children (12 years and older): Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Active Ingredients (In Each Tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Temporarily Relieves Minor Aches And Pains Associated With

  • headache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

Temporarily Relieves Nasal Congestion Due To

  • common cold
  • hay fever or other respiratory allergies

Temporarily

  • reduces fever
  • relieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever
  • promotes nasal and/or sinus drainage; relieves sinus congestion and pressure

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 tablets in 24 hours, which is the maximum daily amount
  • 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
  • with any other drug using the above active ingredients
  • 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
  • glaucoma
  • chronic bronchitis or emphysema
  • difficulty in urination due to enlargement of the prostate gland

When Using This Product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

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

Otc - Pregnancy Or Breast Feeding

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. 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

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*, hypromellose, maltodextrin*, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid

*may contain.

Principal Display Panel - Otis Clapp Valihist Label

Otis Clapp

Quality and Integrity Since 1840

VALIHIST ™

Decongestant-Antihistamine

Pain Reliever-Fever Reducer

Antihistamine- Decongestant

For Allergies, Colds, Runny Nose

See Warnings and Directions on Side Panel

Acetaminophen 325 mg,

Chlorpheniramine Maleate 2mg

Phenylephrine HCl 5 mg

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

New Formula

300 TABLETS (150 PACKETS OF 2)

Principal Display Panel - Medique Medicidin D Label

Medique®

Medicidin-D

Cold and Allergy Relief

Pull to Open

Pain Reliever/ Fever Reducer ● Acetaminophen 325mg

Antihistamine ● Chlorpheniramine Maleate 2mg

Nasal Decongestant ● Phenylephrine HCl 5mg

200Tablets

(100 x 2)

Tamper Evident Unit Dose Packets

* Please review the disclaimer below.