FDA Label for Extra Strength Headache, Caseys 4good
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- REYE’S SYNDROME
- ALLERGY ALERT: ACETAMINOPHEN
- ALLERGY ALERT: ASPIRIN
- LIVER WARNING
- STOMACH BLEEDING WARNING
- CAFFEINE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- EXTRA STRENGTH HEADACHE, 6CT CASEY'S 4GOOD TM
Extra Strength Headache, Caseys 4good Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Drug Facts
Active Ingredients
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin ( NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Purposes
Pain reliever
Pain reliever
Pain reliever aid
Uses
Uses
temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- toothache
- premenstrual & menstrual cramps
Warnings
Warnings
Reye’S Syndrome
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: Acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy Alert: Aspirin
Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Liver Warning
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
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
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
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
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
Ask a doctor or pharmacist before use if you are taking
- 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 A Doctor If
Stop use and ask a 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
These could be signs of a serious condition
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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
Keep out of reach of children. 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
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 as needed; not more than 8 caplets in 24 hours |
children under 12 years | ask a doctor |
Other Information
Other information
- store at 68°-77°F (20°-25°C); excursions permitted between 59°-86°F (15°-30°C)
- avoid excessive heat and humidity
- each caplet contains: Magnesium 0.58 mg
Inactive Ingredients
Inactive ingredients
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc
Questions Or Comments?
Questions or comments?
Call toll-free
1-877-507-6516 (M-F 8 AM-4:30PM CST)
Extra Strength Headache, 6Ct Casey's 4Good Tm
Compare to the
active ingredients
in
Excedrin Extra
Strength
**
EXTRA STRENGTH
Headache
Acetaminophen 250 mg
Pain Reliever
Aspirin (NSAID*) 250 mg
Pain Reliever
Caffeine 65 mg
Pain Reliever Aid
[Casey's logo]
[caplet image]
actual
size
6 CAPLETS
* Please review the disclaimer below.