Aspirin-Free Tension Headache

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-428

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Aspirin-Free Tension Headache 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
• Aspirin-Free Tension Headache Other information
• Inactive ingredients
• Questions or comments?
• Principal display panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg
(formulated with 65 mg caffeine)

Purpose

Pain reliever 

Aspirin-Free Tension Headache Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches 

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 caplets in 24 hours, which is the maxiumum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

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

• new symptoms appear
• symptoms do not get better or worsen
• painful area is red and swollen
• 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 (1-800-222-2222) 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 use more than directed
  (see overdose warning)
• adults and children12 years and over: take 2 caplets every 6 hours.  Do not take mroe than 8 caplets in 24 hours.
• 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) and may cause liver damage

Aspirin-Free Tension Headache Other information

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

Inactive ingredients

corn starch, crospovidone, D&C red #27 aluminum lake, FD&C #2 aluminum lake, FD&C #6 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions or comments?

 1-800-426-9391

Principal display panel

 CVS®
pharmacy

Compare to the active ingredients in Excedrin® Tension Headache*

Aspirin-Free
TENSION HEADACHE
COATED CAPLETS
ACETAMINOPHEN
& CAFFEINE
PAIN RELIEVER/PAIN RELIEVER AID

100 CAPLETS

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Tension Headache.
50844    REV0712C42812

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2012 CVS/pharmacy
www.cvs.com     1-800-shop-cvs

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