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
1001-GBR-2026-0218
- Manufacturer
- Grocery Outlet, Inc.
- Effective date
- 2026-05-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:58:26
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 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed...
Storage and handling
store between 20-25°C (68-77°F) retain carton for complete product information
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 325 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
Warnings
Liver warning
This product contains acetaminophen. 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 the user is allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the user hasliver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user istaking 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.
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 |
|
Other information
- store between 20-25°C (68-77°F)
- retain carton for complete product information
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
1-844-705-4384
PRINCIPAL DISPLAY PANEL
NDC 85828-102-02
Compare to the active ingredient in Tylenol® Regular Strength Tablets*
REGULAR STRENGTH
Acetaminophen
TABLETS, 325 mg
Pain Reliever / Fever Reducer
Contains No Aspirin
GO
Actual Size
100 TABLETS
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Data Matrix | F100102GBR_R1 | F100102GBR_R1.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85828-102-02 | Acetaminophen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 85828-102-02 | Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 3 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- POVIDONE, UNSPECIFIED
- STARCH, PREGELATINIZED CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85828-102 | 85828-102-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-02-18 | monthly-update | 2026-06-03 17:56:39 |
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 | Grocery Outlet, Inc. | 441d1bde-d677-fab7-e063-6394a90aaad4 | 2026-05-21 | Warnings | 85828-102-02 85828-102 85828010202 5256c6cd-f091-0186-e063-6394a90ac2f6 441d1bde-d677-fab7-e063-6394a90aaad4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.