Label: NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
- NDC Code(s): 53345-006-01
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 21, 2024
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- Official Label (Printer Friendly)
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Active ingredients (in each capsule)Acetaminophen 325 mg - Dextromethorphan HBr 15 mg - Doxylamine Succinate 6.25 mg
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PurposePain reliever/ fever reducer - Cough suppressant - Antihistamine
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Usestemporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation - sore throat - headache - minor aches/pains - fever - runny nose & sneezing
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WarningsLiver warning:This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hours, which is the maximum daily amount - with other drugs containing ...
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DO NOT USEDo 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 ...
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Ask a doctor before use if you haveliver disease - glaucoma - cough with excessive phlegm(mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema - difficulty in ...
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Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers - taking the blood thinning drug warfarin
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When using this productdo not exceed the recommended dosage - do not use for more than 7 days - excitability may occur especially in children - marked drowsiness may occur - avoid alcoholic drinks - alcohol, sedatives ...
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STOP USEStop use and Ask a doctor if - you get nervous, dizzy, or sleepless - swelling or redness is present - symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new ...
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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 CHILDRENKeep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems.In case of overdose, get medical help or contact a Poison ...
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Directionstake only as directed - see overdose warning - do not exceed 4 doses per 24 hours - Adults and children 12 years of age and over - Swallow 2 softgels with water every 6 hours - Children 4 to ...
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Other informationstore at room temperature 15°-30°C (59°-86°F) and avoid excessive heat - this product does not contain phenylpropanolamine (PPA)
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Inactive ingredientsD&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink - Manufactured by: Humanwell PuraCap ...
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PRINCIPAL DISPLAY PANEL - Shipping LabelNIGHTTIME COLD AND FLU CAPSULES - Quantity : 4000 Capsules - NDC. No : 53345-006-01 - IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing ...
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INGREDIENTS AND APPEARANCEProduct Information