Label: SEDAL3X- acetaminophen, aspirin, caffeine tablet
- NDC Code(s): 69729-055-40
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 4, 2024
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- Official Label (Printer Friendly)
- Drug facts
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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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 productStomach 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 directedCaffeine 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 diureticAsk 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 - Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 CAPLETS
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INGREDIENTS AND APPEARANCE
SEDAL3X
acetaminophen, aspirin, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-055 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) CROSPOVIDONE (UNII: 2S7830E561) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code S53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-055-40 1 in 1 CARTON 09/07/2022 1 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/07/2022 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations ELYSIUM PHARMACEUTICALS LIMITED 915664486 analysis(69729-055) , label(69729-055) , manufacture(69729-055) , pack(69729-055)