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Tylenol 8HR

Medically reviewed on April 9, 2018

Dosage form: tablet, film coated, extended release
Ingredients: acetaminophen 650mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-309

Tylenol® 8HR

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • minor pain of arthritis
    • toothache
    • premenstrual and menstrual cramps
    • headache
    • the common cold
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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 adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children under 12 years
  • do not use

Other information
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if neck wrap or foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive ingredients

carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-309-02

TYLENOL® 8HR
MUSCLE ACHES & PAIN

Acetaminophen
Extended-release tablets

Pain Reliever / Fever Reducer

For Up to 8 Hours Relief of Minor Muscle Aches & Pain

*Capsule-Shaped Bi-Layer Tablets

Actual Size
100 Caplets*
650 mg each

TYLENOL 8HR 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-309
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen650 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
hypromellose, unspecified 
magnesium stearate 
microcrystalline cellulose 
povidone, unspecified 
powdered cellulose 
Sodium Starch Glycolate Type A Potato 
titanium dioxide 
triacetin 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize21mm
FlavorImprint CodeTYLENOL;ER
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-309-011 BOTTLE in 1 CARTON
124 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
2NDC:50580-309-021 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01987201/18/2016
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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