EXTRA STRENGTH HEADACHE RELIEF
-
acetaminophen,
aspirin and
caffeine tablet, film coated
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
----------
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- sinusitis
- toothache
- premenstrual and menstrual cramps
Warnings
Reye's syndrome:
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert:
Aspirin may cause a severe allergic reaction, which may include:
- hives
- facial swelling
- shock
- asthma (wheezing)
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher is you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Caffeine warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. limit the use of caffeine-containing medication, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do not use
- if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
- 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
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug or are under a doctor's care for any serious condition
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- any new symptoms appear
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- painful area is red or swollen
If pregnant of breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
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 signs or symptoms.
Directions
- do not use more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over
-
take 2 caplets every 6 hours
-
do not take more than 8 caplets in 24 hours
-
children under 12 years: do not use unless directed by a doctor
Other information
- store at controlled room temperature 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
cellulose, hypromellose, polyethylene glycol, providone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, starch, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
PRODUCT PACKAGE
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
CVS®
pharmacy
Extra Strength
HEADACHE RELIEF
COATED CAPLETS
Compare to the active
ingredients in Excedrin®†
See New Warnings
Information
ACETAMINOPHEN, ASPIRIN (NSAID)
AND CAFFEINE
PAIN RELIEVER
PAIN RELIEVER AID
250 CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV0110A33413
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
www.cvs.com
1-800-shop-CVS
| EXTRA STRENGTH HEADACHE RELIEF
acetaminophen, aspirin (nsaid) and caffeine tablet, film coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part343 | 03/13/2008 | |
| Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574) |
| Registrant - L.N.K. International, Inc. (832867837) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| L.N.K. International, Inc | 832867894 | MANUFACTURE | |