DEFENSOLITO- acetaminophen, phenylephrine hydrochloride tablet, chewable

Defensolito by

Drug Labeling and Warnings

Defensolito by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)
Acetaminophen 80 mg

Phenylephrine Hydrochloride 2.5 mg

PURPOSE

Purpose

Pain reliever/ Fever Reducer

Nasal Decongestant

INDICATIONS & USAGE

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

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 USE

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

• with any other products containing acetaminophen (prescription or non-prescription)
• if you are not sure whether a drug contains acetaminophen
• if your child is allergic to acetaminophen or any other ingredients in the product
• for more than 5 days for pain
• for more than 3 days for fever
• who has heart disease, high blood pressure, thyroid disease, or diabetes
• who is taking blood thinning drug warfarin
• if your child has liver disease

STOP USE

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 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting
• nervousness, dizziness, or sleeplessness occur

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive Ingredients Aspartame, Carboxymethylcellulose Sodium, FD&C #40 aluminum lake, Flavor, Lactose, Magnesium Stearate, Polyvinyl Pirrolidone, Silicon Dioxide, Starch, Sugar and Talc.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEFENSOLITO 
acetaminophen, phenylephrine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUGARCANE (UNII: 81H2R5AOH3)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-006-02	50 in 1 CARTON	02/21/2012
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 53145-006-30	1 in 1 BOX	02/21/2012
2		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)