Label: DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 23, 2025

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

  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • ACTIVE INGREDIENT
    Active ingredients (in each caplet) Acetaminophen 325 mg - Dextromethorphan HBr 10 mg - Guaifenesin 200 mg - Phenylephrine HCl 5 mg
  • PURPOSE
    Purpose - Pain reliever/fever reducer - Cough suppressant - Expectorant - Nasal decongestant
  • INDICATIONS & USAGE
    Uses - for the temporary relief of the following cold/flu symptoms: - minor aches and pains - - headache - - sore throat - - nasal congestion - - cough - helps loosen phlegm (mucus) and ...
  • WARNINGS
    Warnings - Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you ...
  • DO NOT USE
    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 ...
  • ASK DOCTOR
    Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - persistent or chronic cough such ...
  • ASK DOCTOR/PHARMACIST
    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
  • WHEN USING
    When using this product do not exceed recommended dose
  • STOP USE
    Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occur - pain, nasal congestion or cough gets worse or lasts more than 7 days - fever gets worse or lasts more than 3 ...
  • PREGNANCY OR BREAST FEEDING
    If pregnant or breast-feeding,  ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN
    Keep out of reach of children. Overdose warning:  In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for ...
  • DOSAGE & ADMINISTRATION
    Directions - do not take more than directed. (see overdose warning) adults and children 12 years and over - take 2 caplets every 4 hours - swallow whole; do not crush, chew or dissolve - do not ...
  • OTHER SAFETY INFORMATION
    Other information - each caplet contains: sodium 3 mg - store at room temperature, between 20º - 25ºC (68º - 77ºF), and avoid excessive heat and humidity
  • INACTIVE INGREDIENT
    Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow no. 10 al. lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc ...
  • QUESTIONS
    Questions or comments? Call - 1-800-632-6900
  • PRINCIPAL DISPLAY PANEL
    675R Kroger Daytime Cold and Flu
  • INGREDIENTS AND APPEARANCE
    Product Information