Tylenol® 8 HR Arthritis Pain

Tylenol® 8 HR Arthritis Pain

Drug Labeling and Warnings

Drug Details

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TYLENOL 8 HR ARTHRITIS PAIN- acetaminophen tablet, extended release 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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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

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

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

  • store between 20-25°C (68-77°F)
  • do not use if carton is opened. Do not use if 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: 50580-783-24

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

24 Caplets*
650 mg each

Principal Display Panel
TYLENOL 8 HR ARTHRITIS PAIN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50580-783
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax (UNII: R12CBM0EIZ)  
hydroxyethyl cellulose (140 mpa.s at 5%) (UNII: 8136Y38GY5)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
povidone, unspecified (UNII: FZ989GH94E)  
powdered cellulose (UNII: SMD1X3XO9M)  
sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
titanium dioxide (UNII: 15FIX9V2JP)  
triacetin (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize21mm
FlavorImprint Code TYLENOL;ER
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50580-783-101 in 1 CARTON07/13/2015
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 50580-783-241 in 1 CARTON07/13/2015
224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC: 50580-783-251 in 1 CARTON07/13/2015
3225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC: 50580-783-291 in 1 CARTON07/13/2015
4290 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC: 50580-783-30290 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2018
6NDC: 50580-783-321 in 1 CARTON08/26/2019
6100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01987207/13/2015
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 5/2019
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division


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