988 Extra Pain Relief Acetaminophen, Aspirin (nsaid) And Caffeine

988 Extra Pain Relief Acetaminophen, Aspirin (nsaid) And Caffeine
SPL v6
SPL
SPL Set ID 9a633bfa-188a-dd42-e053-2995a90ad3aa
Route
ORAL
Published
Effective Date 2022-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (250 mg) Caffeine (65 mg) Acetaminophen
Inactive Ingredients
Silicon Dioxide Titanium Dioxide Starch, Pregelatinized Corn Sodium Starch Glycolate Type A Corn Carnauba Wax Hypromellose, Unspecified Microcrystalline Cellulose Mineral Oil Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL370 Shape: capsule Color: white Size: 18 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-04

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
  • sinusitis
  • cold
  • arthritis
  • muscular aches
  • toothache
  • premenstual 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: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

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)
  • 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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.

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 tablets every 6 hours; not more than 8 tablets in 24 hours
  • children under 12 years: do not use unless directed by 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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
Package Label

Other Information
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Ask Doctor Before Use If
  • 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 are taking a diuretic
  • you have asthma
  • you have liver disease
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00013

V1 RE22HND

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.

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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Stop Using and Ask A Doctor If
  • an allergic reaction occurs. Seek medical help right away.
  • painful area is red or swollen
  • symptoms do not improve
  • any new symptoms appear
  • pain or fever persists or gets worse
  • 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
  • if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product
  • fever gets worse or lasts for more than 3 days
  • pain gets worse or lasts for more than 10 days
Active Ingredient (in Each Tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • sinusitis
  • cold
  • arthritis
  • muscular aches
  • toothache
  • premenstual and 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: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

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)
  • 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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.

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 tablets every 6 hours; not more than 8 tablets in 24 hours
  • children under 12 years: do not use unless directed by 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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
Package Label

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Ask Doctor Before Use If (Ask doctor before use if)
  • 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 are taking a diuretic
  • you have asthma
  • you have liver disease
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00013

V1 RE22HND

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.

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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)
  • an allergic reaction occurs. Seek medical help right away.
  • painful area is red or swollen
  • symptoms do not improve
  • any new symptoms appear
  • pain or fever persists or gets worse
  • 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
  • if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product
  • fever gets worse or lasts for more than 3 days
  • pain gets worse or lasts for more than 10 days
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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