TYLENOL 8 HR ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release 
Johnson & Johnson Consumer Inc.

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Tylenol 8 HR Arthritis Pain

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

adults
  • 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
under 18 years of age
  • ask a doctor

Other information

Inactive ingredients

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

call 1-800-458-2014 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-575-03

TYLENOL ® 8HR

ARTHRITIS PAIN

Acetaminophen
Extended-release tablets

Pain Reliever / Fever Reducer

For The Temporary Relief
Of Minor Arthritis Pain

*Capsule-Shaped
Bi-Layer Tablets

Actual Size

100 Caplets*
650 mg each

tylenol-1

TYLENOL 8 HR ARTHRITIS PAIN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-575
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code TYLENOL;ER
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-575-011 in 1 CARTON01/30/2024
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-575-021 in 1 CARTON01/30/2024
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:50580-575-031 in 1 CARTON01/30/2024
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:50580-575-061 in 1 CARTON01/30/2024
4225 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154401/30/2024
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0e8473ae-ccfe-ba3c-e063-6394a90a6146
Set id: 0391963c-022d-1433-e063-6294a90aac90
Version: 2
Effective Time: 20240109
 
Johnson & Johnson Consumer Inc.