TYLENOL® ARTHRITIS PAIN

TYLENOL  ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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Drug Facts

Active ingredient (in each gelcap)

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 gelcaps 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

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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • 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

  • the tablet got stuck in your throat
  • 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 the reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. 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 gelcaps every 8 hours. Swallow only one gelcap at a time.
  • take a sip of water before swallowing each gelcap and wash each gelcap down with water (up to a full 8 oz glass)
  • swallow whole – do not crush, chew, split or dissolve
  • do not take more than 6 gelcaps 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 at 20–25°C (68–77°F). Avoid high humidity.
  • do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken
  • see end panel for lot number and expiration date

Inactive ingredients

benzyl alcohol, butylparaben, castor oil, corn starch, edetate calcium disodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, gelatin, hydroxyethyl cellulose, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, povidone, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-508-20

Push
& Turn
Cap

TYLENOL®

ARTHRITIS
PAIN

Acetaminophen Extended Release Pain Reliever/Fever Reducer
For The Temporary Relief Of Minor Arthritis Pain

20 GELCAPS-650 mg each

Gelcaps*
*Gelatin-Coated Capsule-Shaped Tablets

Principal Display Panel - 20 Gelcap Carton
TYLENOL   ARTHRITIS PAIN
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-508
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
butylparaben 
castor oil 
starch, corn 
edetate calcium disodium 
FD&C blue no. 1 
FD&C blue no. 2 
aluminum oxide 
gelatin 
hypromelloses 
magnesium stearate 
methylparaben 
cellulose, microcrystalline 
povidones 
powdered cellulose 
propylene glycol 
propylparaben 
shellac 
sodium lauryl sulfate 
sodium propionate 
sodium starch glycolate type a potato 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorImprint Code Tylenol;Arthritis;650
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-508-201 in 1 CARTON
120 in 1 BOTTLE, PLASTIC
2NDC:50580-508-401 in 1 CARTON
240 in 1 BOTTLE, PLASTIC
3NDC:50580-508-801 in 1 CARTON
380 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01987201/01/201010/25/2013
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 11/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc