Label: PEDIACARE-COUGH-RUNNYNOSE- acetaminophen,chlorpheniramine maleate,dextromethorphan liquid
- NDC Code(s): 59556-852-58
- Packager: Strides Pharma 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 August 7, 2017
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- Official Label (Printer Friendly)
- Drug Facts
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Active ingredients(in each 5 mL) Acetaminophen 160 mg - Chlorpheniramine maleate 1 mg - Dextromethorphan HBr 5 mg
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PurposeAcetaminophen 160 mg…………….Fever reducer/Pain reliever - Chlorpheniramine maleate 1 mg……Antihistamine - Dextromethorphan HBr 5 mg………Cough suppressant
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Usestemporarily relieves the following cold/flu symptoms: minor aches and pains - cough - headache - sore throat - sneezing and runny nose - temporarily reduces fever
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WarningsLiver warning: This product contains acetaminophen. Sever liver damage may occur if the child takes: more than 5 doses in 24 hours, which is the maximum daily amount - with other drugs ...
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Do not useto make a child sleepy - in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's ...
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Ask a doctor before use if the child hasglaucoma - liver disease - a breathing problem such as chronic bronchitis - cough that occurs with excessive phlegm (mucus) persistent or chronic cough such as occurs with asthma
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Ask a doctor or pharmacist before use if child is takingsedatives or tranquilizers - the blood thinning drug warfarin
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When using this productdo not exceed recommended dosage (see overdose warning) may cause excitability, especially in children - marked drowsiness may occur - sedatives and tranquilizers may increase ...
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Stop use and ask a doctor ifnew symptoms occur - fever gets worse or lasts for more than 3 days - redness or swelling is present - pain or cough gets worse or lasts for more than 5 days - cough comes back or ...
- Keep out of reach of children
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Overdose WarningTaking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center ...
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Directionsdo not exceed recommended dosage (see overdose warning) do not use in infants - this product does not contain directions or complete warnings for adult use. shake well before ...
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Inactive ingredientscitric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose / carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose ...
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PRINCIPAL DISPLAY PANELPediaCare® Children Cough & Runny Nose - Fever, Sore Throat & Sneezing - 4 FL OZ FL (118 mL) Cherry Flavor - Carton - Container Label - TOP - Container Label - Base - Container Label ...
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INGREDIENTS AND APPEARANCEProduct Information