Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain from arthritis toothache the common cold premenstrual and menstrual cramps temporarily reduces fever
CVS 44-678-Acetaminophen
- Manufacturer
- CVS PHARMACY | LNK International, Inc.
- Effective date
- 2026-06-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:35:20
Label at a glance#
ProductAcetaminophen Regular Strength
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years and over take 2 gelcaps every 4 to 6 hours while symptoms last do not take more than 10 gelcaps 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) avoid high humidity use by expiration date on package
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each gelcap)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain from arthritis
- toothache
- the common cold
- 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
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
- redness or swelling is present
- any new symptoms appear
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of 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 gelcaps every 4 to 6 hours while symptoms last
- do not take more than 10 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- take 2 gelcaps every 4 to 6 hours while symptoms last
- children under 12 years: ask a doctor
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- use by expiration date on package
Inactive ingredients
corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
Principal display panel
NDC 69842-876-51
♥CVS™
actual size
Regular Strength
ACETAMINOPHEN
Pain Reliever, Fever Reducer, 325 mg
Compare to Tylenol® Regular Strength
active ingredient*
365 GELCAPS
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Regular Strength
- Acetaminophen
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- FERROSOFERRIC OXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- SHELLAC
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-876 | 69842-876-51 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 10 | 2026-04-07 | full-release | 2026-06-01 01:53:01 |
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 Regular Strength | ACETAMINOPHEN | CVS PHARMACY | 5e35df92-6282-4ca6-902b-bb6bd326b487 | 2026-06-23 | Warnings | 69842-876-51 69842-876 69842087651 495a115c-520e-437b-853a-0522486b885d 5e35df92-6282-4ca6-902b-bb6bd326b487 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.