Defensol D

Defensol D
SPL v5
SPL
SPL Set ID f466c660-69eb-4581-81ff-1499fa421d8b
Route
ORAL
Published
Effective Date 2017-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Blue No. 2 Hypromellose 2208 (100 Mpa.s) Magnesium Stearate Polyethylene Glycol 400 Povidone Starch, Pregelatinized Corn Silicon Dioxide Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: round Color: blue Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-02-21

Description

Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpherinamine maleate 2 mg Phenylephrine HCI 5 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

Temporarily relieves these symptoms associated with cold or flu:

  • headache
  • nasalcongestion
  • 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

Dosage and 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

Description

Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpherinamine maleate 2 mg Phenylephrine HCI 5 mg

Section 34088-5

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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
Section 50567-7

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
Section 50568-5

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

Section 50569-3

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
Section 50570-1

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.
Section 51727-6

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

Section 51945-4

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Pain Reliever/ Fever Reducer

Antihistamine

Nasal Decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpherinamine maleate 2 mg

Phenylephrine HCI 5 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves these symptoms associated with cold or flu:

  • headache
  • nasalcongestion
  • 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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain Reliever/ Fever Reducer

Antihistamine

Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpherinamine maleate 2 mg

Phenylephrine HCI 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)