Valumeds Extra Strength Headache Relief, Acetaminophen, Aspirin And Caffeine

Valumeds Extra Strength Headache Relief, Acetaminophen, Aspirin And Caffeine
SPL v1
SPL
SPL Set ID 0f864e73-e4b8-4e23-8990-8439ac17bd58
Route
ORAL
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Acetylsalicylic Acid (65 mg) Caffeine
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Water Stearic Acid Talc

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-25

Description

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

Purpose

Pain reliever Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Description

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

Uses

temporarily relieves minor aches and pains due to:

  • headache 
  • a cold 
  • arthritis 
  • muscular aches
  • sinusitis 
  • toothache 
  • premenstrual & 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 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 caplets 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 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.

Directions
  • do not use more than directed (see Overdose warning)
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor
Do Not Use
  • if you have 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.
Drug Facts

Other Information
  • each caplet contains: magnesium 0.58 mg
  • store at controlled room temperature 20º - 25º C (68º - 77º F)
  • read all product information before using.
Package Labeling:

Inactive Ingredients

colloidal silicon dioxide, hypermellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, talc

Questions Or Comments?

contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Ask 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 heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have high blood pressure
  • you have asthma
Stop Use and Ask 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
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • any new symptoms appear

These could be signs of a serious condition.

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

In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are 
  • any other drug containing an NSAID (prescription or non-prescription)
  • a prescription drug for diabetes, gout or arthritis
  • any other drug, or are under a doctor's care for any serious condition
  • a blood thinning (anticoagulant) or steroid drug

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

  • headache 
  • a cold 
  • arthritis 
  • muscular aches
  • sinusitis 
  • toothache 
  • premenstrual & menstrual cramps
Purpose

Pain reliever

Pain reliever

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 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 caplets 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 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.

Directions
  • do not use more than directed (see Overdose warning)
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • if you have 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.
Drug Facts

Other Information (Other information)
  • each caplet contains: magnesium 0.58 mg
  • store at controlled room temperature 20º - 25º C (68º - 77º F)
  • read all product information before using.
Package Labeling:

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypermellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, talc

Questions Or Comments? (Questions or comments?)

contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Ask Doctor Before Use If (Ask 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 heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have high blood pressure
  • you have asthma
Stop Use and Ask Doctor If (Stop use and ask 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
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • any new symptoms appear

These could be signs of a serious condition.

If Pregnant Or Breast Feeding (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 (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are  (Ask a doctor or pharmacist before use if you are )
  • any other drug containing an NSAID (prescription or non-prescription)
  • a prescription drug for diabetes, gout or arthritis
  • any other drug, or are under a doctor's care for any serious condition
  • a blood thinning (anticoagulant) or steroid drug

Advanced Ingredient Data


Raw Label Data

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