Defensolito

Menper Distributors, Inc.

FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each tablet)
Acetaminophen 80 mg

Phenylephrine Hydrochloride 2.5 mg

Purpose

Purpose

Pain reliever/ Fever Reducer

Nasal Decongestant

Uses

Uses

Temporarily relieves

• nasal decongestion due to a common cold, hay fever or other upper respiratory allergies, nasal stuffiness, sinus congestion and pressure
• minor aches and pains associated with the common cold, sore throat, headache, tootheache and flu

Warnings

Do not exceed recommended dosage. Do not give to children under 6 years of age.

Liver toxicity may occur if

• recommended dosage is exceeded
• used with other products containing acetaminophen
• used with moderate amounts of alcohol

Drug Interaction Precaution: Do not use in a child who is taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or Parkinson's Disease), or for two weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Do not give this product to a child unless directed by a doctor:

• with any other products containing acetaminophen
• for more than 5 days for pain
• for more than 3 days for fever
• for more than 2 days for sore throat
• who has heart disease, high blood pressure, thyroid disease, or diabetes
• who is taking blood thinning drug warfarin

Stop use and ask doctor promptly if

• pain persists and gets worse, if new symptoms occur or if redness or swelling is present because these could be signs of a serious condition
• symptoms do not improve or are accompanied by a fever
• if sore throat is severe, persists for more than 3 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting
• nervousness, dizziness, or sleeplessness occur

If pregnant or breast feeding, ask a health care 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 children even if you do not notice any signs or symptoms

Directions

• Do not take more than 6 doses (12 chewable tablets) in a 24 hour period
• Children 6 to under 12 years of age: Take 2 chewable tablets every 4 hours
• Children under 6 years of age: Consult a doctor.

Other information

• phenylketonurics: Contains phenylalanine 7 mg per tablet

Store at controlled room temperature 15°-30°C (59°-86°F)

Tamper Evident feature: Do not use if the pouch is broken or torn

Inactive Ingredients Aluminum Lake Red #40, Aspartame, Carboxymethylcellulose Sodium, Flavor, Lactose, Magnesium Stearate, Polyvinyl Pirrolidone, Silicon Dioxide, Starch, Sugar and Talc.

Questions? Call 1-800-560-5223 weekdays 9 AM-4 PM EST