Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 7b5263ad-01b7-4fc5-9384-4da8efe89e35
Route
ORAL
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-04-30
Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

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

Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 tbsp) (3,000 mg) in 24 hours. 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 ever 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.

Directions
  • do not take more than directed (see overdose warning)
  • do not take more then 4 doses in any 24 hours 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.



Product Label
CVS HEALTH Extra Strength Acetaminophen Cherry Flavor
Other Information
  • each 15 mL contains:sodium 6 mg 
  • store between 20-25ºC (68-77ºF) do not refrigerate
  • protect from light
Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Extra Strength Tylenol®*

EXTRA STRENGTH

Acetaminophen, Liquid 500 mg

Pain reliever; Fever reducer

For Ages 12 & over

Cherry flavor

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®. 

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, PI 02895

CVS.com

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each 15 Ml)

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

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

Pain reliever/fever reducer

Warnings

Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 tbsp) (3,000 mg) in 24 hours. 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 ever 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.

Directions
  • do not take more than directed (see overdose warning)
  • do not take more then 4 doses in any 24 hours 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.



Product Label
CVS HEALTH Extra Strength Acetaminophen Cherry Flavor
Other Information (Other information)
  • each 15 mL contains:sodium 6 mg 
  • store between 20-25ºC (68-77ºF) do not refrigerate
  • protect from light
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Extra Strength Tylenol®*

EXTRA STRENGTH

Acetaminophen, Liquid 500 mg

Pain reliever; Fever reducer

For Ages 12 & over

Cherry flavor

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®. 

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, PI 02895

CVS.com

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each 15 Ml) (Active ingredient (in each 15 mL))

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.886272 · Updated: 2026-03-14T23:02:37.591705