Sedalmex Forte

Sedalmex Forte
SPL v1
SPL
SPL Set ID 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d
Route
ORAL
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Microcrystalline Cellulose Povidone K30 Polyethylene Glycol, Unspecified Starch, Corn Stearic Acid Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

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


Medication Information

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Description

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

Uses

temporarily relieves minor aches and pains due to:

• headache  • muscular aches    • arthritis pain

• a cold       • toothache            • premenstrual and menstrual cramps

Section 42229-5

Fast Headache Relief!

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by 

Belmora LLC, 3033 Wilson BLvd.,

Suite 700. Arlington, VA 22201,                                                              

MADE IN INDIA

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.

Packaging

Directions

• do not use more than directed

• drink a full glass of water with each dose



Adults and children:

(12 years and older)

 Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours
 Children under 12 years:   Ask a doctor

Drug Facts

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?

1-888-779-2877 M-F 9AM-5PM EST

Active Ingredients (in Each Tablet)

Acetaminophen        250 mg

Aspirin (NSAID*)   250 mg

Caffeine                   65 mg

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

• headache  • muscular aches    • arthritis pain

• a cold       • toothache            • premenstrual and menstrual cramps

Section 42229-5 (42229-5)

Fast Headache Relief!

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by 

Belmora LLC, 3033 Wilson BLvd.,

Suite 700. Arlington, VA 22201,                                                              

MADE IN INDIA

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

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.

Packaging

Directions

• do not use more than directed

• drink a full glass of water with each dose



Adults and children:

(12 years and older)

 Take 2 Tablets every 6 hours as needed; not more than 8 tablets in 24 hours
 Children under 12 years:   Ask a doctor

Drug Facts

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-779-2877 M-F 9AM-5PM EST

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Acetaminophen        250 mg

Aspirin (NSAID*)   250 mg

Caffeine                   65 mg

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)