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
Acetaminophen
- Manufacturer
- CVS PHARMACY, INC
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:09
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure15 sections
Dosage and administration
do not take more than directed (see overdose warning) 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 use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Storage and handling
store between 20-25°C (68-77°F). See USP Controlled Room Temperature. see bottom of the label for lot number and expiration date
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen USP, 500 mg
Purpose
Pain reliever/fever reducer
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
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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product
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
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 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 use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
Other information
store between 20-25°C (68-77°F). See USP Controlled Room Temperature.
see bottom of the label for lot number and expiration date
Inactive ingredients
hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal display Panel
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-177-15 | Acetaminophen | 150 in 1 BOTTLE | TABLET | 150 | 5 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- STEARIC ACID
- STARCH, CORN
- POVIDONE K30
- HYPROMELLOSE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-177 | 51316-177-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | 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 | 1ddb8a2b-3081-3eda-e063-6294a90ab82b | 2025-12-19 | Warnings | 51316-177-15 51316-177 51316017715 46545d0f-6657-d84a-e063-6394a90a2028 1ddb8a2b-3081-3eda-e063-6294a90ab82b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.