DEFENSOL D (MULTI SYMPTOM EFFERVESCENT TABLETS)- acetaminophen 250mg, chlorpheniramine maleate 2mg, dextromethorphan hydrobromide 10mg, phenylephrine hydrochloride 5mg tablet, effervescent

Defensol D (Multi Symptom Effervescent Tablets) by

Drug Labeling and Warnings

Defensol D (Multi Symptom Effervescent Tablets) by is a Otc medication manufactured, distributed, or labeled by Menper Distributors Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients (in each tablet)  Purposes
Acetaminophen 250 mg…………………………………………………Pain Relieve/fever reducer
Chlorpheniramine maleate 2mg ……………………………………Antihistamine
Dextromethorphan hydrobromide 10mg……………………….Cough suppressant
Phenylephrine hydrochloride 5mg………………………………...Nasal decongestant

Purposes

Active Ingredients (in each tablet) Purposes
Acetaminophen 250 mg…………………………………………………Pain Relieve/fever reducer
Chlorpheniramine maleate 2mg ……………………………………Antihistamine
Dextromethorphan hydrobromide 10mg……………………….Cough suppressant
Phenylephrine hydrochloride 5mg………………………………...Nasal decongestant

Uses: Temporarily relieves these symptoms due to a cold or flu:

Minor aches and pains
Headache
Cough
Sore throat
Runny nose
Nasal and sinus congestion
Temporarily reduces fever

Warnings:

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

More than 8 tablets in 24 hours, which is the maximum daily amount for this product
With other dugs containing acetaminophen
3 or more alcoholic drinks while using this product

Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to sedate children.

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.
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions), 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.
If you have ever had an allergic reaction to this product or any of its ingredients
In children under 12 years of age

Ask a doctor before use if you have:

Liver disease
Heart disease
High blood pressure
Thyroid disease
Diabetes
Glaucoma
Cough with excessive phlegm (mucus)
A breathing problem such as emphysema or chronic bronchitis
Difficulty in urination due to enlargement of the prostate gland
Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
A sodium restricted diet

Ask a doctor or pharmacist before use if you are:

Taking the blood thinning medicine warfarin
Taking sedatives or tranquilizers

When using this product:

Do not exceed the recommended dosage
May cause marked drowsiness
Avoid alcoholic drinks
Alcohol, sedatives, and tranquilizers may increase drowsiness
Be careful when driving a motor vehicle or operating machinery
Excitability may occur, especially in children

Stop use and ask a doctor if:

Pain, cough, 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
Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Nervousness, dizziness, or sleeplessness occurs

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

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

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Do not take more than the recommended dose
Adults and children 12 years and over: take 2 tablets fully dissolved in 4oz. of water every four hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor
Children under 12 years: do not use

Other Information:

Store at room temperature. Avoid excessive heat
Total Sodium: 406.73mg/tablet
Total Potassium: 3mg/tablet

Inactive Ingredients

Acesulfame potassium, sucralose, citric acid anhydrous, polysorbate 80, mannitol, orange flavor, PVP K-30, simethicone, sodium benzoate, sodium bicarbonate, color FD&C red #40

Defensol D Effervescent - Outer Carton.jpg

Defensol D Effervescent Pouch.jpg

INGREDIENTS AND APPEARANCE

DEFENSOL D (MULTI SYMPTOM EFFERVESCENT TABLETS) 
acetaminophen 250mg, chlorpheniramine maleate 2mg, dextromethorphan hydrobromide 10mg, phenylephrine hydrochloride 5mg tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-320
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg  in 250
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 250
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 250
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 250

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE K30 (UNII: U725QWY32X)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	30mm
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-320-06	6 in 1 BOX	12/01/2015
1	NDC: 53145-320-02	2 in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2015

Labeler - Menper Distributors Inc. (101947166)