SPL v2
SPL
SPL Set ID 8ffb02d9-92df-4d2f-a367-1c71490807fb
Route
ORAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Purpose

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


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Description

Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Stop Use

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 appear

These could be signs of a serious condition.

Warnings

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 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 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

Questions

Questions or comments? (888) 602-0288

Ask Doctor

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
Do Not Use

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
Active Ingredient

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredient

Inactive ingredients

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

Indications & Usage

Uses

temporarily relieves minor aches and pains due to

  • headache
  • muscular aches
  • arthritis pain
  • a cold
  • toothache
  • premenstrual and menstrual cramps
Ask Doctor/pharmacist

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for gout, diabetes, or arthritis
  • taking any other drug, or under a doctor's care for any serious condition
Dosage & Administration

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 caplets every 6 hours as needed; not more than 8 caplets in 24 hours

Children under 12 years: Ask a doctor

Other Safety Information

Other information

  • read all product information before using. Keep box for important information.
  • store at room temperature 68º-77ºF (20º-25ºC)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • each caplet contains: Magnesium 0.58 mg
Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health 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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel – 100 Caplet Box Label

2533

ProvisionPlus

PAIN TERMINATOR

Advanced Severe Pain Formula

Fast Relief of:

  • Headaches
  • Muscle Aches
  • Back Aches
  • Arthritis Pain

100 Tablets

2 Per Packet


Structured Label Content

Purpose (PURPOSE)

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Stop Use (STOP USE)

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 appear

These could be signs of a serious condition.

Warnings (WARNINGS)

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 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 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

Questions (QUESTIONS)

Questions or comments? (888) 602-0288

Ask Doctor (ASK DOCTOR)

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
Do Not Use (DO NOT USE)

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
Active Ingredient (ACTIVE INGREDIENT)

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients

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

Indications & Usage (INDICATIONS & USAGE)

Uses

temporarily relieves minor aches and pains due to

  • headache
  • muscular aches
  • arthritis pain
  • a cold
  • toothache
  • premenstrual and menstrual cramps
Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for gout, diabetes, or arthritis
  • taking any other drug, or under a doctor's care for any serious condition
Dosage & Administration (DOSAGE & ADMINISTRATION)

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 caplets every 6 hours as needed; not more than 8 caplets in 24 hours

Children under 12 years: Ask a doctor

Other Safety Information (OTHER SAFETY INFORMATION)

Other information

  • read all product information before using. Keep box for important information.
  • store at room temperature 68º-77ºF (20º-25ºC)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • each caplet contains: Magnesium 0.58 mg
Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

If pregnant or breast-feeding, ask a health 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.

Keep Out of Reach of Children (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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel – 100 Caplet Box Label

2533

ProvisionPlus

PAIN TERMINATOR

Advanced Severe Pain Formula

Fast Relief of:

  • Headaches
  • Muscle Aches
  • Back Aches
  • Arthritis Pain

100 Tablets

2 Per Packet


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)