Tylenol Arthritis Pain description, usages, side effects, indications, overdosage, supplying and lots more!

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Tylenol Arthritis Pain

McNeil Consumer Healthcare Div McNeil-PPC, Inc

TYLENOL Arthritis Pain Extended Release Caplet


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Active ingredient (in each caplet)                     Purpose
Acetaminophen 650 mg …………………………….…………….Pain reliever/fever reducer

Tylenol Arthritis Pain Uses

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

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.

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

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 caplets every 8 hours with water
  • swallow whole – do not crush, chew 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

Tylenol Arthritis Pain Other information

  • store at 20-25°C (68-77°F). Avoid excessive heat 40°C (104°F).
  • 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

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

Questions or comments? call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-112-15

Push & Turn Cap

TYLENOL®

ARTHRITIS PAIN

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

150 CAPLETS 650 mg each

Caplets*
*Capsule-Shaped Tablets

Tylenol Arthritis Pain

Tylenol Arthritis Pain

Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-112
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
STARCH, CORN
hypromellose
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone
POWDERED CELLULOSE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm Tylenol;ER OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-112-22 2 in 1 POUCH
2 NDC:50580-112-22 2 in 1 POUCH
3 225 in 1 BOTTLE
4 NDC:50580-112-22 2 in 1 POUCH
5 100 in 1 BOTTLE
6 120 in 1 BOTTLE
7 150 in 1 BOTTLE
8 NDC:50580-112-21 100 in 1 BOTTLE
9 24 in 1 BOTTLE
10 250 in 1 BOTTLE
11 290 in 1 BOTTLE
12 50 in 1 BOTTLE
13 190 in 1 BOTTLE
14 NDC:50580-112-59 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019872 1998-12-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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