Thompson Extra Strength Non-aspirin

Thompson Extra Strength Non-aspirin
SPL v3
SPL
SPL Set ID f837c31f-24e5-a8df-e053-6394a90a0b36
Route
ORAL
Published
Effective Date 2023-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Potato Stearic Acid Starch, Corn Povidone Hypromellose, Unspecified Povidone, Unspecified Titanium Dioxide Polyethylene Glycol, Unspecified Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: G552 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-04

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg 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

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.

Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever fever.

Dosage and Administration

Directions

  • do not use more than directed (see overdose warning)

​Adults and children: (12 years and over)

  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

Children under 12 years: Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Overdose warning: 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.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

Section 50568-5

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
Section 50570-1

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 are allergic to acetaminophen or any of the inactive ingredients in this product
Section 51727-6

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*

*may contain

Section 51945-4

Extra Strength Non-Aspirin

Pain Reliever/ Fever Reducer

Thompson

Safety Works | Business Thrives ™

Pull to Open

This Package is for Households without Young Children.

Aches, Fever

Acetaminophen 500 MG

100 Tablets

Tamper Evident Sealed Packets

Section 53413-1

Questions or comments? 877.506.4291

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient

Acetaminophen 500 mg

Section 60561-8

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever fever.

Dosage and Administration (34068-7)

Directions

  • do not use more than directed (see overdose warning)

​Adults and children: (12 years and over)

  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

Children under 12 years: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg 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

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: 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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
Section 50570-1 (50570-1)

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 are allergic to acetaminophen or any of the inactive ingredients in this product
Section 51727-6 (51727-6)

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*

*may contain

Section 51945-4 (51945-4)

Extra Strength Non-Aspirin

Pain Reliever/ Fever Reducer

Thompson

Safety Works | Business Thrives ™

Pull to Open

This Package is for Households without Young Children.

Aches, Fever

Acetaminophen 500 MG

100 Tablets

Tamper Evident Sealed Packets

Section 53413-1 (53413-1)

Questions or comments? 877.506.4291

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient

Acetaminophen 500 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)