Label: DEFENSOL D (MULTI SYMPTOM EFFERVESCENT TABLETS)- acetaminophen 250mg, chlorpheniramine maleate 2mg, dextromethorphan hydrobromide 10mg, phenylephrine hydrochloride 5mg tablet, effervescent
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Contains inactivated NDC Code(s)
NDC Code(s): 53145-320-02, 53145-320-06 - Packager: Menper Distributors Inc.
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purposes
- Uses: Temporarily relieves these symptoms due to a cold or flu:
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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 dugs containing acetaminophen
• 3 or more alcoholic drinks while using this productSore 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.
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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 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:
• 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:
- When using this product:
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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 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
- Directions:
- Other Information:
- Inactive Ingredients
- Defensol D Effervescent - Outer Carton.jpg
- Defensol D Effervescent Pouch.jpg
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INGREDIENTS AND APPEARANCE
DEFENSOL D (MULTI SYMPTOM EFFERVESCENT TABLETS)
acetaminophen 250mg, chlorpheniramine maleate 2mg, dextromethorphan hydrobromide 10mg, phenylephrine hydrochloride 5mg tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-320 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg in 250 CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 250 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 250 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg in 250 Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SUCRALOSE (UNII: 96K6UQ3ZD4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MANNITOL (UNII: 3OWL53L36A) POVIDONE K30 (UNII: U725QWY32X) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color white Score no score Shape ROUND Size 30mm Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-320-06 6 in 1 BOX 12/01/2015 1 NDC:53145-320-02 2 in 1 POUCH; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/01/2015 Labeler - Menper Distributors Inc. (101947166)