Defensol D (Multi Symptom Effervescent Tablets)

Manufacturer
Menper Distributors Inc.
Effective date
2016-01-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:34

Label at a glance#

ProductDefensol D (Multi Symptom Effervescent Tablets)
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

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

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

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:

OTC - DO NOT USE SECTION

• 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:

OTC - ASK DOCTOR SECTION

• 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:

OTC - ASK DOCTOR/PHARMACIST SECTION

• Taking the blood thinning medicine warfarin
• Taking sedatives or tranquilizers

When using this product:

OTC - WHEN USING SECTION

• 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:

OTC - STOP USE SECTION

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• 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:

DOSAGE & ADMINISTRATION SECTION

• 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:

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Defensol D Effervescent - Outer Carton.jpgDefensol D Effervescent - Outer Carton.jpg

Defensol D Effervescent Pouch.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Defensol D Effervescent Pouch.jpgDefensol D Effervescent Pouch.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSN1
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCD1
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-320-062020-01-31C16284748780-19d75b9d0-d74a-f424-e053-dadaa90a57ceDefensol D (Multi Symptom Effervescent Tablets)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-320-02Defensol D (Multi Symptom Effervescent Tablets)2 in 1 POUCHTABLET, EFFERVESCENT21
53145-320-06Defensol D (Multi Symptom Effervescent Tablets)6 in 1 BOXTABLET, EFFERVESCENT61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53145-320DEFENSOL D (MULTI SYMPTOM EFFERVESCENT TABLETS) (ACETAMINOPHEN 250MG, CHLORPHENIRAMINE MALEATE 2MG, DEXTROMETHORPHAN HYDROBROMIDE 10MG, PHENYLEPHRINE HYDROCHLORIDE 5MG) TABLET, EFFERVESCENT [MENPER DISTRIBUTORS INC.]1Legacy NDC, 2 package rows20160107_bb3b29d2-d705-48b9-8893-8a8ce4694bfb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-32053145-320-02, 53145-320-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cebe9de8-5579-4129-8a93-3ac761ac3784bb3b29d2-d705-48b9-8893-8a8ce4694bfb2016-01-05WarningsExact identifier
spl id: cebe9de8-5579-4129-8a93-3ac761ac3784
spl set id: bb3b29d2-d705-48b9-8893-8a8ce4694bfb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.