Acetaminophen PM

Dolgencorp, LLC

Rexall 44-556

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients
• Purpose
• Acetaminophen PM Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Acetaminophen PM Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep-aid

Acetaminophen PM Uses

 temporarily 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

• 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

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

When using this product

• drowsiness will occur
• aboid alcoholic beverages
• do not drive a motor vehicle or operate machiner 

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 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. 

Acetaminophen PM Other information

• store at controlled room temperature 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

 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, pregelatinied starch, propylene gllycol, shellac glaze, stearic acid, titanium dioxide

Principal Display Panel

Since 1903 Rexall®

EXTRA STRENGTH PM Pain Relief

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

SEE NEW WARNINGS INFORMATION

• Pain reliever

• Nighttime sleep-aid

• Fast release

• Non-habit forming 

20

 Rapid Release

Gelcaps