Label: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE capsule, liquid filled
- NDC Code(s): 35916-0189-1
- Packager: SOFTGEL HEALTHCARE PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Active Ingredients (in each capsule)
Acetaminophen USP 325 mg - Dextromethorphan HBr USP 10 mg - Doxylamine Succinate USP 6.25 mg
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Purposes
Pain reliever/fever reducer - Cough suppressant - Antihistamine
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Uses
• temporarily relieves these symptoms due to a cold or flu - : • minor aches and pains • headache • cough - • sore throat • nasal and sinus congestion - • temporarily reduces fever
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - • more than 4,000 mg of acetaminophen in 24 hours - • with other drugs containing acetaminophen - • 3 ...
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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 ...
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Ask a doctor before use if you have
• liver disease • heart disease • high blood pressure - • thyroid disease • diabetes - • cough that occurs with excessive phlegm (mucus) • difficulty in urination due to enlargement of the prostate ...
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ASK DOCTOR/PHARMACISTAsk a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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WHEN USINGWhen using this product do not exceed recommended dosage
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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 ...
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PREGNANCY OR BREAST FEEDINGIf pregnant or breast-feeding, ask a health professional before use.
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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 ...
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Directions
• do not take more than the recommended dose - • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. ...
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Other Information
• store at room temperature. Avoid excessive heat above 40ºC (104ºF).
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Inactive ingredients
D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide
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Bulk package Label
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INGREDIENTS AND APPEARANCEProduct Information