Label at a glance#

ProductAcetaminophen Extra Strength

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL (2 TBSP) in the dosing cup provided every 6 hours while symptoms last do not take more than 90 mL (6 TBSP) in 24 hours, unless directed by a doctor do not take for more than 10 day...

Storage and handling

each 30 mL dose cup contains: sodium 11 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

PhoneLabel contact1-800-SHOP CVS

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL = 1 tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

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

temporarily reduces fever

Warnings

WARNINGS SECTION

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:

blisters
rash
skin reddening

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over

take 30 mL (2 TBSP) in the dosing cup provided every 6 hours while symptoms last
do not take more than 90 mL (6 TBSP) 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

Other information

STORAGE AND HANDLING SECTION

each 30 mL dose cup contains: sodium 11 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium saccharin, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health_™

Compare to the active ingredient
in Tylenol^®Extra Strength*

Liquid

EXTRA STRENGTH
Acetaminophen
Liquid, 500 mg

Pain reliever, Fever reducer
•Aspirin Free •Alcohol Free

DYE FREE

Cherry Flavor

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Tylenol^®
Extra Strength.

50844 REV0917A04519

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2019 CVS/pharmacy CVS.com^®
1-800-SHOP CVS V-11112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69842-945-19	ML - Milliliter	69842-945	c6f2e58a-973c-4a5b-a96e-8417c25f5232	1	2018-05-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Acetaminophen Extra Strength
Acetaminophen
ANHYDROUS CITRIC ACID
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM METABISULFITE
SACCHARIN SODIUM
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-945	69842-945-19

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ac463ba9-4fdb-4be0-8df6-8be7e0f9b5f1			da86de80-43cb-4ba9-b228-4bd7a6bac4f1	2023-01-11	Warnings	Exact identifier spl id: ac463ba9-4fdb-4be0-8df6-8be7e0f9b5f1 spl set id: da86de80-43cb-4ba9-b228-4bd7a6bac4f1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.