Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
ACETAMINOPHEN
- Manufacturer
- FOODHOLD U.S.A., LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
- Effective date
- 2019-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:01:36
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 and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless direc...
Storage and handling
store at room temperature 15°-30°C (59°-86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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
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 |
|
children 6-11 years |
|
children under 6 years | ask a doctor |
Other information
- store at room temperature 15°-30°C (59°-86°F)
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
Questions or Comments?
Call toll free: 1-855-215-8180
PRINCIPAL DISPLAY PANEL - Bottle Label
CAREONE ACETAMINOPHEN 325 mg 40 SOFTGELS
PAIN RELIEVER FEVER REDUCER
NDC 41520-982-25
*Compare to the active ingredient in TYLENOL® Regular Strength
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41520-982-25 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6cae-d83d-e063-dadaa90ab31f | ACETAMINOPHEN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41520-982-25 | ACETAMINOPHEN | 40 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 40 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41520-982 | 41520-982-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| 83ad6ce4-31cb-4966-8c60-3ac21edb0d47 | d065351c-9a39-4800-8f8e-1fba4d6bbae8 | 2019-11-21 | Warnings | 83ad6ce4-31cb-4966-8c60-3ac21edb0d47 d065351c-9a39-4800-8f8e-1fba4d6bbae8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.