Extra Strength Pain Reliever

FRED'S, INC.

Freds 44-531

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Extra Strength Pain Reliever 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 Reliever Other information
• Inactive ingredients
• Principal display panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Extra Strength Pain Reliever Uses

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

Warnings

Liver warning: This product contains acetaminophen.  The maximum daily dose of this product is 6 tablets (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 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 ore 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 (1-8000-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Directions

• do not take more than directed
  (see overdose warning)
• adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
• children under 12 years: do not use this 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 Reliever Other information

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

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient 

Principal display panel

FRED'S_®

Extra Strength Non-Aspirin
Pain Reliever
Pain Reliever/Fever Reducer

Acetaminophen
EZ Tabs
100 Tablets - 500 mg each

Tested Against The Active Ingredient In:
Extra Strength TYLENOL^®  EZ TABS^†

^†This product is not manufactured or distributed McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol^® EZ Tabs.

50844        REV0213D53112

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