DEFENSOL D- acetaminophen, chlorpherinamine maleate, phenylephrine hci tablet

Defensol D by

Drug Labeling and Warnings

Defensol D 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 325 mg

Chlorpherinamine maleate 2 mg

Phenylephrine HCI 5 mg

PURPOSE

Purpose

Pain Reliever/ Fever Reducer

Antihistamine

Nasal Decongestant

INDICATIONS & USAGE

Uses

Temporarily relieves these symptoms associated with cold or flu:

• headache
• nasal congestion
• sore throat
• fever
• minor aches and pains

Temporarily relieves minor aches, pains and headache as well as these sympotoms of hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• nasal congestion
• itching of the nose or throat
• itchy, watery eyes

Temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

WARNINGS

Warnings

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

• more than 8 tablets in any 24-hour period, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning: if sore throat is severe, persits for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

DO NOT USE

Do not use

• To sedate a child or to make a child sleepy
• 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 two 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.
• with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

ASK DOCTOR

Ask doctor before use if you have

• liver desease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
•  trouble urinating due to an enlarged prostate gland
• glaucoma
•  a breathing problem such as emphysema, asthma, or chronic bronchitis

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking any other oral nasal decongestant or stimulant
• taking any other pain reliever/ fever reducer
• taking sedatives or tranquilizers

WHEN USING

When using this product

• do not use more than directed
• excitability may occur with children
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

STOP USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: 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.

DOSAGE & ADMINISTRATION

Directions: do not take more than 8 tablets in a 24 hour period.

• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage

• age: dose
• adults and children 12 years and over: 2 tablets every 4 hours
• children under 12 years: do not use

INACTIVE INGREDIENT

Inactive ingredients: FD&C blue #2, hypromellose, magnesium stearate, PEG 400, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

QUESTIONS

Questions? Menper Distributors, Inc. 1-800-560-5223; M-F 9 AM - 4 PM Eastern

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEFENSOL D 
acetaminophen, chlorpherinamine maleate, phenylephrine hci tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-005-02	50 in 1 CARTON	02/21/2012
1		2 in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 53145-005-30	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 not final	part343	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)