FDA Label for Sedalmex Forte

Drug Facts

Active Ingredients (In Each Tablet)

Acetaminophen        250 mg
Aspirin (NSAID*)   250 mg
Caffeine                   65 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:

• headache  • muscular aches    • arthritis pain

• a cold       • toothache            • premenstrual and 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: 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 (NSAIDs) 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 tablets 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)
• take more or for a longer time than directed 
• have 3 or more alcoholic drinks every day while using this product 

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 heart beat.

Do not use 

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• If you ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/fever reducers

Ask a doctor before use if
• stomach bleeding warning applies to you
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 
• you are taking a diuretic • you have a history of stomach problems, such as heartburn
• you have asthma • you have liver disease

Ask a doctor or pharmacist before use if you are

• if you are taking prescription drug for gout, diabetes, or arthritis
• taking any other drug, or under a doctor’s care for any serious condition

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

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen 
• any new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health care 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.

Directions

• do not use more than directed
• drink a full glass of water with each dose

Other Information

• read all product information before using. Keep box for important information.

• store at room temperature between 68°-77°F (20°-25°C)

• avoid excessive heat and humidity 

• tamper evident sealed packets

• do not use any opened or torn packets

• each tablet contains: Magnesium 0.58 mg 

Inactive Ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc

Questions Or Comments?

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Packaging

image description - 27854 303