MEDIQUE ONSET FORTE- acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet, film coated
Unifirst First Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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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	Item Code (Source)	NDC:47682-102
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	162.5 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	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	green (green)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	M1
Contains

Packaging
#	Item Code	Package Description
1	NDC:47682-102-64	12 in 1 BOX, UNIT-DOSE
1	NDC:47682-102-99	2 in 1 PACKET
2	NDC:47682-102-33	50 in 1 BOX, UNIT-DOSE
2	NDC:47682-102-99	2 in 1 PACKET
3	NDC:47682-102-13	250 in 1 BOX, UNIT-DOSE
3	NDC:47682-102-99	2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 10/2010

Document Id: 0db43959-a4c9-450d-b483-6f6f12385dec

Set id: c8dea1e9-95d2-468d-9126-7400c92dc44f

Version: 2

Effective Time: 20101007

Unifirst First Aid Corporation