Sedal 3X
Drug facts
OTC - PURPOSE SECTION
Active ingredients (in each caplets)
Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Uses
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual and menstrual cramps
Warnings
Allergy alert
Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing)
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, wich 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 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 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 have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away if: 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 or 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.
Overdose warning
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 use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor
Other information
store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
SPL UNCLASSIFIED SECTION
Manufactured in: GMP Registered Facility in the USA
Made for:
inov FARMACEUTIQUE
Exclusively distributed by: OPMX Chula Vista, CA 91910 PHONE: 619-600-5632
SPL UNCLASSIFIED SECTION
Sedal3x
Acetaminophen 250 mg
Aspirin 250 mg Caffeine 65 mg
Pain Reliever
40 Caplets