RxNorm Names
HEADACHE RELIEF EXTRA STRENGTH
(acetaminophen, aspirin, caffeine)
tablet
[SMART SENSE (Kmart)]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=564e0bac-0ed2-4d03-9628-2052408c1615| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- sinusitis
- toothache
- premenstrual & 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
- asthma (wheezing)
- shock
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 if 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 medications, 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 have ever had an allergic reaction to acetaminophen, 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 are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
taking
- any other drug containing an NSAID (prescription or nonprescription)
- a blood thinning (anticoagulant) or steroid drug
- a prescription drug for diabetes, gout, or arthritis
- any other drug, or are under a doctor’s care for any serious condition
Stop use and ask doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms appear
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; not more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
Other information
- store at controlled room temperature 20º-25ºC (68º-77ºF)
- excursions permitted to 15ºC to 30ºC (59º-86ºF)
Inactive ingredients
hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, and triglycerides
Principal Display Panel
Compare to the active ingredients of Excedrin® Extra Strength**
EXTRA STRENGTH
HEADACHE RELIEF
Acetaminophen, Aspirin (NSAID)* and Caffeine
Pain Reliever/Pain Reliever Aid
GLUTEN FREE
CAPLETS
**This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength.
Distributed by: Kmart Corporation
Hoffman Estates, IL 60179
Shop kmart.com
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
| HEADACHE RELIEF
EXTRA STRENGTH
acetaminophen, aspirin, caffeine tablet |
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| Labeler - SMART SENSE (Kmart) (008965873) |
| Registrant - P and L Development of New York Corporation (800014821) |
Review RxNorm Normal Forms