Label:
DEFENSOL D (MULTI SYMPTOM EFFERVESCENT TABLETS)- acetaminophen 250mg, chlorpheniramine maleate 2mg, dextromethorphan hyd...
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  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 5, 2016

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  • Active Ingredients
    Active Ingredients (in each tablet)  Purposes - Acetaminophen 250 mg…………………………………………………Pain Relieve/fever reducer - Chlorpheniramine maleate 2mg ……………………………………Antihistamine - Dextromethorphan ...
  • Purposes
    Active Ingredients (in each tablet) Purposes - Acetaminophen 250 mg…………………………………………………Pain Relieve/fever reducer - Chlorpheniramine maleate 2mg ……………………………………Antihistamine - Dextromethorphan ...
  • 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 ...
  • 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 ...
  • 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 - ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 - Outer Carton.jpg
  • Defensol D Effervescent Pouch.jpg
    Defensol D Effervescent Pouch.jpg
  • INGREDIENTS AND APPEARANCE
    Product Information