Label at a glance#

ProductCVS Health Extra Strength Acetaminophen Softgels

Active ingredientACETAMINOPHEN

Label structure17 sections

Indications and 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

Dosage and administration

do not take more than directed (see Overdose warning ) Adults and children 12 years and over ■ take 2 softgels every 6 hours while symptoms last ■ do not take more than 6 softgels in 24 hours unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Storage and handling

■ each softgel contains : sodium 7 mg ■ store between 15°-30°C (59°-86°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-333-9792

PhoneLabel contact1-800-SHOP CVS

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

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:
■ the common cold ■ headache ■ backache
■ minor pain of arthritis ■ toothache ■ muscular aches
■ premenstrual and menstrual cramps
■ 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:
■ skin reddening ■ blisters ■ rash
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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - STOP USE SECTION

■ 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see Overdose warning)


Adults and children 12 years and over	■ take 2 softgels every 6 hours while symptoms last ■ do not take more than 6 softgels in 24 hours unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ each softgel contains: sodium 7 mg
■ store between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,
potassium hydroxide, povidone, propylene glycol, purified
water, sodium hydroxide, sorbitol, sorbitol sorbitan solution
titanium dioxide

OTC - QUESTIONS SECTION

Questions or Comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the active ingredient
in Tylenol® Extra Strength*
Liquid Gels**

EXTRA STRENGTH
Acetaminophen USP 500mg

Pain Reliever; Fever reducer
Aspirin free
40 SOFTGELS**
**Liquid filled capsules

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured
or distributed by McNeil Consumer
Healthcare, owner of the
registered trademark Tylenol®
Extra Strength.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
V-35257
#960109

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198439	acetaminophen 500 MG Oral Capsule	PSN	7
198439	acetaminophen 500 MG Oral Capsule	SCD	7
198439	APAP 500 MG Oral Capsule	SY	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-636-40	CVS Health Extra Strength Acetaminophen Softgels	40 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	40		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-636	CVS HEALTH EXTRA STRENGTH ACETAMINOPHEN SOFTGELS (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [CVS PHARRMACY]	7	Legacy NDC, 1 package rows	20241219_b2715622-cb9a-4ca3-a2e0-a0dffabd7a5d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

CVS Health Extra Strength Acetaminophen Softgels
ACETAMINOPHEN
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
POTASSIUM HYDROXIDE
POVIDONE K30
PROPYLENE GLYCOL
SODIUM HYDROXIDE
WATER
SORBITAN
SORBITOL
TITANIUM DIOXIDE
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-636	69842-636-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
POVIDONE K30	U725QWY32X	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
FD&C RED NO. 40	WZB9127XOA	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
297de631-c783-4771-e063-6294a90afab6			b2715622-cb9a-4ca3-a2e0-a0dffabd7a5d	2024-12-17	Warnings	Exact identifier spl id: 297de631-c783-4771-e063-6294a90afab6 spl set id: b2715622-cb9a-4ca3-a2e0-a0dffabd7a5d

Reported adverse events (FAERS/openFDA)#

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