Extra Strength Pain Reliever PM

FRED'S, INC.

Freds 44-556

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

Active ingredients (in each gelcap)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Extra Strength Pain Reliever PM Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• 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
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• drowsiness will occur
• avoid alcoholic beverages
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

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 or symptoms.

Directions

• do not take more than directed
  (see overdose warning)
• adults and children 12 years and over: take 2 gelcaps at bedtime. Do not take more than 2 gelcaps of this product in 24 hours.
• children under 12 years: do not use
  

Extra Strength Pain Reliever PM 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

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Principal Display Panel

fred's®

Non-habit forming

Extra Strength
Pain Reliever PM
Acetaminophen
Diphenhydramine HCl

Pain Reliever/Nighttime Sleep Aid

40 Rapid Release Gelcaps

Compare to the active ingredients in:
Extra Strength TYLENOL^® PM*

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^® PM.
50844    REV0413C55610