FDA Label for Sedal3x
View Indications, Usage & Precautions
- OTC - PURPOSE
- USES
- ALLERGY ALERT
- LIVER WARNING
- STOMACH BLEEDING WARNING
- CAFFEINE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTHER
- PRINCIPAL DISPLAY PANEL - 40 CAPLETS
Sedal3x Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc. 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.
Otc - Purpose
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
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
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
Other
Manufactured in:
GMP Registered Facility in the USA
Made for:
inov FARMACEUTIQUE
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
PHONE: 619-600-5632
Sedal3x
Acetaminophen 250 mg
Aspirin 250 mg
Caffeine 65 mg
Pain Reliever
40 Caplets
Principal Display Panel - 40 Caplets
NDC 69729-105-40
Sedal3x
Acetaminophen 250 mg Pain reliever
Aspirin 250 mg Pain reliever
Caffeine 65 mg Pain reliever
40 Caplets
* Please review the disclaimer below.