Label: DAY TIME GELCAP- acetaminophen, dextromethorphan, phenylephrine capsule, liquid filled

  • 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 January 18, 2013

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  • Active ingredients(in each GelCap)
    Acetaminophen 325mg - Dextromethorphan HBr 10mg - Phenylephrine HCl 5mg
  • Purpose
    Pain reliever/fever reducer - Cough suppressant - Nasal decongestant
  • Uses
    temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation - sore throat - headache - minor aches and pains - fever - nasal congestion
  • Warnings
    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 4 doses in 24 hrs, which is the maximum daily amount for this product - with other drugs ...
  • Directions
    take only as directed-see Overdose warning - do not exceed 4 doses per 24 hours - adults and children 12 yrs and over2 GelCaps with water every 4 hrs - children 4 to under 12 yrsask a ...
  • Other information
    store at room temperature
  • Inactive ingredients
    FDC red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobitol special
  • PRINCIPAL DISPLAY PANEL
    Daytime gelcap
  • INGREDIENTS AND APPEARANCE
    Product Information