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Tylenol

Cardinal Health

Tylenol 325 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen Regular Strength

Drug Facts

Active Ingredient

(in each caplet) Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

This package is intended for institutional use only. Keep this and all drugs out of the reach of children.

Tylenol Uses

For Hospital and Government Use Only

Temporarily relieves minor aches and pains

due to: the common cold, headache, backache, minor pain of arthritis, toothache, premenstrual and menstrual cramps, and temporarily reduces fever.

Do not use if pouch is opened

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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.

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking blood thinning drug warfarin.

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 an signs or symptoms.

Directions

Directions do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 4 to 6 hours while symptoms last
  • do not take more than 12 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 caplet every 4 to 6 hours while symptoms last
  • do not take more than 5 caplets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 years do not use this adult product in children under 6 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

Inactive ingredients

Carnauba wax, castor oil, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

Storage

Store between 20-25 C (68-77 F)

Other

See New Warnings Information

Distributed by:

McNeil Consumer Healthcare

DIVISION OF MCNEIL - PPC, INC.

FORT WASHINGTON, PA 19034 USA

visit us at www.tylenol.com or call toll-free

1-877-TYLENOL (1-877-895-3665)

Questions or comments? call 1-877-895-3665

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Tylenol® 325 MG

Acetaminophen

Regular Strength

10 Caplets

Tylenol

Tylenol

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-1918(NDC:50580-501)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm TYLENOL;325;HOSPITAL CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-1918-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-06


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Be sure to consult your doctor before taking any medication!
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