Medique Onset Forte description, usages, side effects, indications, overdosage, supplying and lots more!

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Medique Onset Forte

Unifirst First Aid Corporation

Medique® Onset Forte


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 162.5 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

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 for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

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 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.

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity

Inactive ingredients

corn starch, D&C yellow # 10, FD&C blue # 1, magnesium silicate, magnesium stearate, microcrystalline cellulose, povidone, silica, sodium starch glycolate, stearic acid

Questions or comments? 1-800-634-7680

102R Medique Onset Forte Label

Medique®

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See inside flap for more details

Onset Forte

Multi-Symptom Relief

Acetaminophen/ Acetaminofeno 162.5mg

Chlorpheniramine Maleate/ Maleato de Clorfeniramina 2mg

Phenylephrine HCl/Hidrocloruro de Fenilefrina 5mg

Easy To Swallow

Film Coated Tablets

Facil de Tragar Tabletas con Cubierta Pelicular

Pull to Open

Tire Para Abrir

See new warnings information

500 Tablets

(250 x 2)

Allergy, Cold, & Hay Fever Relief

Alivio a las alergias, el resfriado y la fiebro del heno

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Untarias

Medique Onset Forte

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:47682-102
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 162.5 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
D&C YELLOW NO. 10
FD&C BLUE NO. 1
magnesium silicate
MAGNESIUM STEARATE
povidone
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
green (green) 8 mm M1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47682-102-99 2 in 1 PACKET
2 NDC:47682-102-99 2 in 1 PACKET
3 NDC:47682-102-99 2 in 1 PACKET
4 NDC:47682-102-13 250 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-12-30


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Be sure to consult your doctor before taking any medication!
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