Extra Strength Pain Relief

Greenbrier International, Inc.

Assured 44-519

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each gelcap)
• Purpose
• Extra Strength Pain Relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Extra Strength Pain Relief Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever / fever reducer

Extra Strength Pain Relief Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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 uding this product

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

• do not take more than directed (see overdose warning)
• adults and children 12 years and over
  • take 2 gelcaps every 4 to 6 hours while symptoms last
  • do not take more than 8 gelcaps in 24 hours
  • do not take for more than 10 days unlesss directed by a doctor
• children under 12 years of age: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Extra Strength Pain Relief Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• avoid high humidity
• see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl, cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simithicone, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

*COMPARE TO ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS

Extra Strength
Pain Relief
Acetaminophen 500 mg
Pain reliever / Fever reducer
contains no aspirin

12 Rapid Release gelcaps

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.
50844          REV0513B51902