Maximum Strength Non-aspirin

Maximum Strength Non-aspirin
SPL v3
SPL
SPL Set ID 1d3e9948-883e-4668-9bb8-d699a283b51a
Route
ORAL
Published
Effective Date 2024-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Microcrystalline Cellulose Povidone, Unspecified Sodium Starch Glycolate Type A Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-02-02

Description

Drug Facts

Purpose

pain reliever/fever reducer


Medication Information

Purpose

pain reliever/fever reducer

Description

Drug Facts

Use

temporarily relieves fever and minor aches and pains associated with:

  • headache
  • backache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothaches
  • menstrual cramps
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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 53414-9

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

Directions

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor Children under 12 years of age: Do not use this product; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

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
Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

Liver Warning

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

  • More than 8 tablets (4000mg of acetaminophen) 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
Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of 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.

Other Information
  • do not use if packet is opened or torn
  • store at room temperature 59-86℉ (15-30℃)
  • avoid excessive heat and humidity
Inactive Ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

Stop Use and Ask Doctor If
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.
Active Ingredient (in Each Tablets)

Acetaminophen 500 mg

Principal Display Panel 100 Tablet Box

Product #1122

Maximum Strength

Non-Aspirin

Active ingredient:

Acetaminophen

Pain Reliever/Fever Reducer

  • Temporary relief from minor aches, pain, and fever
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308. 1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

100 Tablets • 2 Tablets Per Packet

Principal Display Panel 250 Tablet Box

Product #1124

Maximum Strength

Non-Aspirin

Active ingredient:

Acetaminophen

Pain Reliever/Fever Reducer

  • Temporary relief from minor aches, pain, and fever
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308. 1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet


Structured Label Content

Use

temporarily relieves fever and minor aches and pains associated with:

  • headache
  • backache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothaches
  • menstrual cramps
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 53414-9 (53414-9)

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

Purpose

pain reliever/fever reducer

Directions

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor Children under 12 years of age: Do not use this product; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

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
Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

Liver Warning

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

  • More than 8 tablets (4000mg of acetaminophen) 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
Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In case of 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.

Other Information
  • do not use if packet is opened or torn
  • store at room temperature 59-86℉ (15-30℃)
  • avoid excessive heat and humidity
Inactive Ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.
Active Ingredient (in Each Tablets) (Active ingredient (In Each Tablets))

Acetaminophen 500 mg

Principal Display Panel 100 Tablet Box (PRINCIPAL DISPLAY PANEL - 100 Tablet Box)

Product #1122

Maximum Strength

Non-Aspirin

Active ingredient:

Acetaminophen

Pain Reliever/Fever Reducer

  • Temporary relief from minor aches, pain, and fever
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308. 1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

100 Tablets • 2 Tablets Per Packet

Principal Display Panel 250 Tablet Box (PRINCIPAL DISPLAY PANEL - 250 Tablet Box)

Product #1124

Maximum Strength

Non-Aspirin

Active ingredient:

Acetaminophen

Pain Reliever/Fever Reducer

  • Temporary relief from minor aches, pain, and fever
  • Soothes muscles aches and minor arthritis pain
  • Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308. 1-2015 standards. They are sealed in

tamper-evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet


Advanced Ingredient Data


Raw Label Data

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