SPL v2
SPL
SPL Set ID 1608b4f0-bf20-4024-b8f2-20a4df7a4b21
Route
ORAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Red No. 33 Fd&c Red No. 40 High Fructose Corn Syrup Propylene Glycol Polyethylene Glycol, Unspecified Water Sodium Benzoate Sorbitol Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

(In each 15 mL) in Acetaminophen 500 mg............. Pain reliever/fever reducer

Purpose

(In each 15 mL) in Acetaminophen 500 mg............. Pain reliever/fever reducer


Medication Information

Purpose

(In each 15 mL) in Acetaminophen 500 mg............. Pain reliever/fever reducer

Description

(In each 15 mL) in Acetaminophen 500 mg............. Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever
Section 34088-5

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.

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

Section 42229-5
  • TAMPER EVIDENT: Do not use if the safety seal around or under the cap is broken or missing
  • *Compare to Active Ingredient in Tylenol® Extra Strength*
  • *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Distributed by C.D.M.A, Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new sympthoms 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 53414-9

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

Section 55105-1
  • Pain Reliever
  • Fever Reducer
Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 skin reaction occurs, stop use and seek medical help right away.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
  • 30 mL every 6 hours while symptoms last
  • do not take more than 10 days unless directed by a doctor
  • children under 12 years: 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Other Information
  • each 15 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • protect from light.

Questions or comments

1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium,

sodium benzoate, sorbitol

Principal Display Panel

Active Ingredient                         purpose

(In each 15 mL)

in Acetaminophen 500 mg............. Pain reliever/fever reducer


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever
Section 34088-5 (34088-5)

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.

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

Section 42229-5 (42229-5)
  • TAMPER EVIDENT: Do not use if the safety seal around or under the cap is broken or missing
  • *Compare to Active Ingredient in Tylenol® Extra Strength*
  • *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Distributed by C.D.M.A, Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new sympthoms 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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
  • Pain Reliever
  • Fever Reducer
Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 skin reaction occurs, stop use and seek medical help right away.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
  • 30 mL every 6 hours while symptoms last
  • do not take more than 10 days unless directed by a doctor
  • children under 12 years: 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Other Information (Other information)
  • each 15 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • protect from light.

Questions or comments

1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive Ingredients (Inactive ingredients)

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium,

sodium benzoate, sorbitol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Active Ingredient                         purpose (Active Ingredient                         Purpose)

(In each 15 mL)

in Acetaminophen 500 mg............. Pain reliever/fever reducer


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)