The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Defensol D (multi Symptom Effervescent Tablets) (NDC 53145-320). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses: temporarily relieves these symptoms due to a cold or flu:, warnings:, do not use:, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are:, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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
• Minor aches and pains
• Headache
• Cough
• Sore throat
• Runny nose
• Nasal and sinus congestion
• Temporarily reduces fever
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.
• 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
• 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
• Taking the blood thinning medicine warfarin
• Taking sedatives or tranquilizers
• 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
• 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.
• 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.
• 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
• Store at room temperature. Avoid excessive heat
Total Sodium: 406.73mg/tablet
Total Potassium: 3mg/tablet
Acesulfame potassium, sucralose, citric acid anhydrous, polysorbate 80, mannitol, orange flavor, PVP K-30, simethicone, sodium benzoate, sodium bicarbonate, color FD&C red #40
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