Extra Strength Pain Relief PM

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-235

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Extra Strength Pain Relief 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 Relief PM Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Extra Strength Pain Relief 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

• if you are allergic to acetaminophen or any of the inactive ingredients in this product

• in children under 12 years of age

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• liver disease

• trouble urinating due to an enlarged prostate gland

• glaucoma

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 caplets at bedtime. Do not take more than 2 caplets 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.

Extra Strength Pain Relief PM Other information

• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS®
pharmacy

Compare to the active ingredients in Extra Strength Tylenol® PM*

Extra Strength
PAIN RELIEF PM    
CAPLETS

ACETAMINOPHEN
DIPHENHYDRAMINE HCl

Pain reliever / Nighttime sleep aid

value size
500 caplets

*This product is not manufactured for distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
50844          REV0512E23514

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

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