TYLENOL Extra Strength description, usages, side effects, indications, overdosage, supplying and lots more!

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TYLENOL Extra Strength

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

TYLENOL Extra Strength


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

TYLENOL Extra Strength Uses

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

Warnings

Liver warning

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 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 and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor

TYLENOL Extra Strength Other information

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

Inactive ingredients

carnauba waxcontains one or more of these ingredients, castor oilcontains one or more of these ingredients, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycolcontains one or more of these ingredients, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

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NDC 50580-449-09

TYLENOL ®

Pain Reliever
Fever Reducer
Acetaminophen

EXTRA
STRENGTH

For Adults

100 CAPLETS
500 mg each

Caplets

TYLENOL  Extra Strength

TYLENOL Extra Strength

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-449
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
castor oil
STARCH, CORN
FD&C RED NO. 40
ALUMINUM OXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POWDERED CELLULOSE
propylene glycol
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 18 mm TYLENOL;500 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 125 in 1 BOTTLE, PLASTIC
2 24 in 1 BOTTLE, PLASTIC
3 NDC:50580-449-08 2 in 1 POUCH
4 100 in 1 BOTTLE, PLASTIC
5 NDC:50580-449-08 2 in 1 POUCH
6 NDC:50580-449-08 2 in 1 POUCH
7 NDC:50580-449-08 2 in 1 POUCH
8 NDC:50580-449-14 2 in 1 POUCH
9 NDC:50580-449-15 10 in 1 VIAL, PLASTIC
10 150 in 1 BOTTLE, PLASTIC
11 36 in 1 BOTTLE, PLASTIC
12 NDC:50580-449-34 325 in 1 BOTTLE, PLASTIC
13 24 in 1 BOTTLE, PLASTIC
14 100 in 1 BOTTLE, PLASTIC
15 225 in 1 BOTTLE, PLASTIC
16 NDC:50580-449-62 325 in 1 BOTTLE, PLASTIC
17 NDC:50580-449-84 2 in 1 POUCH
18 NDC:50580-449-84 2 in 1 POUCH
19 NDC:50580-449-84 2 in 1 POUCH
20 NDC:50580-449-84 2 in 1 POUCH
21 NDC:50580-449-87 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1984-08-19


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Be sure to consult your doctor before taking any medication!
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