Label: PEDIACARE-COUGH-RUNNYNOSE- acetaminophen,chlorpheniramine maleate,dextromethorphan liquid

  • 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

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active ingredients
    (in each 5 mL) Acetaminophen 160 mg - Chlorpheniramine maleate 1 mg - Dextromethorphan HBr 5 mg
  • Purpose
    Acetaminophen 160 mg…………….Fever reducer/Pain reliever - Chlorpheniramine maleate 1 mg……Antihistamine - Dextromethorphan HBr 5 mg………Cough suppressant
  • Uses
    temporarily relieves the following cold/flu symptoms: minor aches and pains - cough - headache - sore throat - sneezing and runny nose - temporarily reduces fever
  • Warnings
    Liver 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 ...
  • Do not use
    to 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 ...
  • Ask a doctor before use if the child has
    glaucoma - 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
  • Ask a doctor or pharmacist before use if child is taking
    sedatives or tranquilizers - the blood thinning drug warfarin
  • When using this product
    do not exceed recommended dosage (see overdose warning) may cause excitability, especially in children - marked drowsiness may occur - sedatives and tranquilizers may increase ...
  • Stop use and ask a doctor if
    new 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
  • Overdose Warning
    Taking 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 ...
  • Directions
    do 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 ...
  • Inactive ingredients
    citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose / carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose ...
  • PRINCIPAL DISPLAY PANEL
    PediaCare® 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information