Defensol D description, usages, side effects, indications, overdosage, supplying and lots more!

Defensol D

Menper Distributors, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert



FULL PRESCRIBING INFORMATION

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

Uses

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

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

  • 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 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 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 this product

  • 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 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

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

Keep out of reach of children.

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.

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

Other information

Store at room temperature: 15-130°C (59-86°F).

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

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

Defensol D

Acetaminophen, Chlorpherinamine maleate, Phenylephrine HCI TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53145-005
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 2
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
povidone
STARCH, PREGELATINIZED CORN
SILICON DIOXIDE
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Shape
blue 10 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 PACKAGE
2 NDC:53145-005-02 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-02-21


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Be sure to consult your doctor before taking any medication!
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