Indications and uses
temporarily relieves minor aches and pains due to the common cold headache toothache muscular aches backache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Acetaminophen
- Manufacturer
- CVS Pharmacy, Inc
- Effective date
- 2024-12-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:41:05
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
do not take more than directed (see overdose warning). adults and children 12 years of age 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 of age ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to the common cold headache toothache
muscular aches
backache
minor pain of arthritis
premenstrual and menstrual cramps
temporarily reduces fever
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.
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
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.
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.
OVERDOSAGE SECTION
Overdose warning: 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
do not take more than directed (see overdose warning).
| adults and children
12 years of age 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 of age | ask a doctor |
Other information
Store in a dry place at 15° – 30°C (59° – 86°F)
INACTIVE INGREDIENT SECTION
corn starch, hypromellose, mineral oil, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions or comments?
Call 1-800-231-4670
SPL UNCLASSIFIED SECTION
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CVS Health
Compare to the active ingredient in Extra Strength Tylenol®*
Extra Strength
Acetaminophen
Caplets 500 mg
Pain reliever; Fever reducer
1000 Caplets
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-864-01 | Acetaminophen | 2 in 1 CELLO PACK | TABLET, FILM COATED | 2 | 2 | |
| 69842-864-04 | Acetaminophen | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 2 | |
| 69842-864-05 | Acetaminophen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- STEARIC ACID
- LIGHT MINERAL OIL
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- HYPROMELLOSES
- POLYETHYLENE GLYCOL 400
- POVIDONE K30
- TITANIUM DIOXIDE
- TALC
- SODIUM LAURYL SULFATE
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-864 | 69842-864-04, 69842-864-05, 69842-864-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | CVS Pharmacy, Inc | c4473ee6-4e01-1ec2-e053-2995a90ac513 | 2024-12-02 | Warnings | 69842-864-05 69842-864-01 69842-864-04 69842-864 69842086405 69842086401 69842086404 28514e58-59a8-094a-e063-6394a90a1c7d c4473ee6-4e01-1ec2-e053-2995a90ac513 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.