Indications and uses
temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Acetaminophen
- Manufacturer
- CVS PHARMACY | LNK International, Inc.
- Effective date
- 2022-04-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:02:14
Label at a glance#
ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets 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
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
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 a skin reaction occurs, stop use and seek medical help right away.
Do not use
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
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 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.
In case of accidental 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.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets 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
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid
Questions or comments?
1-800-426-9391
Principal Display Panel
♥︎CVSHealth™
Compare to the active ingredient in
Extra Strength Tylenol® Caplets*
Caplets
EXTRA STRENGTH
Acetaminophen
Caplets 500 mg
Pain reliever, Fever reducer
50 COATED CAPLETS +
10 CT TRAVEL VIAL
Actual Size
Actual Bottle
Size on Top Panel
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol® Caplets.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-11112
CVS® Quality
Money Back Guarantee
50844 REV0617A17511
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Extra Strength
- Acetaminophen
- CASTOR OIL
- HYPROMELLOSE, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STARCH, CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-759 | 69842-759-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0aa52e6c-9b5d-4c67-a3e1-a7f8d3e96022 | 7a747130-adff-4f4c-88dc-edc622ae8748 | 2022-04-29 | Warnings | 0aa52e6c-9b5d-4c67-a3e1-a7f8d3e96022 7a747130-adff-4f4c-88dc-edc622ae8748 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.