Label:
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT- acetaminophen, dextromethorphan hydrobromide, chlorpheni...
view full title

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 7, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION
    EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT DAY - Drug Facts
  • ACTIVE INGREDIENT
    Active ingredients (in each caplet)Purpose - Acetaminophen 500 mgPain reliever/fever reducer - Dextromethorphan HBr 15 mgCough suppressant
  • Uses
    ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains - ■ headache - ■ sore throat - ■ cough - ■ temporarily reduces fever
  • Warnings
    Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - ■ more than 4,000 mg of acetaminophen in 24 hours - ■ with other drugs containing ...
  • Directions
    do not take more than directed (see - overdose warning) adults and children 12 years and over - ■ take 2 caplets every 6 hours while symptoms last - ■ do not take more ...
  • Other information
    ■ store between 20 - 25°C (68 - 77°F) ■ do not use if blister unit is torn or broken​
  • Inactive ingredients
    carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide
  • Questions or comments?
    call - 1-877-895-3665 (toll-free) or - 215-273-8755 (collect)
  • SPL UNCLASSIFIED SECTION
    EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT NIGHT - Drug Facts
  • ACTIVE INGREDIENT
    Active ingredients (in each caplet) Purpose - Acetaminophen 500 mg - Pain reliever/fever reducer - Chlorpheniramine maleate 2 mgAntihistamine - Dextromethorphan HBr 15 mgCough ...
  • Uses
    ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains - ■ headache - ■ sore throat - ■ cough - ■ sneezing and runny nose - ■ temporarily reduces fever
  • Warnings
    Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - ■ more than 4,000 mg of acetaminophen in 24 hours - ■ with other drugs containing acetaminophen ...
  • 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 adults as well as for children even if you do not ...
  • Directions
    do not take more than directed (see - overdose warning) adults and children 12 years and over - ■ take 2 caplets every 6 hours while symptoms last - ■ do not take more ...
  • Other information
    ■ store between 20 - 25°C (68 - 77°F) ■ do not use if blister unit is torn or broken​
  • Inactive ingredients
    carnauba wax, FD&C Blue no.1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, powdered cellulose, pregelatinized starch, sodium ...
  • Questions or comments?
    call - 1-877-895-3665 (toll-free) or - 215-273-8755 (collect)
  • PRINCIPAL DISPLAY PANEL(What is this?)
    NDC 50580-551-01 - EXTRA STRENGTH - TYLENOL - ® FOR ADULTS - SEVERE COUGH + SORE THROAT - NEW! DOSAGE + DIRECTIONS - Acetaminophen, Dextromethorphan HBr - Pain Reliever-Fever ...
  • INGREDIENTS AND APPEARANCE
    Product Information