Label: ACETAMINOPHEN 325MG, DEXTROMETHORPHAN HBR 10MG AND PHENYLEPRINE HCL 5MG- acetaminophen, dextromethorphan hbr and phenyle...view full title
- NDC Code(s): 35916-0188-1
- Packager: Softgel Healthcare Private Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 19, 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 softgelatin capsule)
Acetaminophen USP 325 mg - Dextromethorphan HBr USP 10 mg - Phenylephrine HCl USP 5 mg
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Purposes
Pain reliever/fever reducer - Cough suppressant - Nasal decongestant
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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 - ...
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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 with excessive phlegm (mucus) ● difficulty in urination due to enlargement of the prostate gland - ...
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Ask 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 comes back or occurs with ...
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If 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 ...
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Other information
● store at room temperature. Avoid excessive heat above 40ºC (104ºF).
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Inactive ingredients
FD&C yellow no.5, FD&C yellow no.6, 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