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 Tablets
- Manufacturer
- Central Texas Community Health Centers
- Effective date
- 2016-03-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:45:23
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 12 tablets in 24 hours 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 children under 6 years do not use this adult product in children under 6 years of age; this will provide mor...
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:
- 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. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
OTC - DO NOT USE SECTION
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.
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 and in children 12 years and over
- 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
Taking more than the recommended dose (overdose) may cause liver damage. 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
crospovidone, methylparaben, povidone, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid
SPL UNCLASSIFIED SECTION
Distributed By McKesson
One Post Street, San Francisco, CA 94104
PRINCIPAL DISPLAY PANEL - 325 MG Tablet Bottle Label
CommUnityCare Federally Qualified Health Centers
ACETAMINOPHEN
325MG #30 TABS
Date:
Name:
Dr.
TAKE AS DIRECTED.
123456
1/1/01
ACETAMINOPHEN 325mg #30 NDC 76413-301-30
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-301-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3220-f424-e053-dadaa90a57ce | Acetaminophen Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-301-30 | Acetaminophen | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-973-10 | EA - Each | 49348-973 | 8272bb6e-93f6-4ca2-82ca-97ae0df96841 | 1 | 2014-05-02 |
| 49348-973-16 | EA - Each | 49348-973 | 57cf5560-9dba-42c7-a98c-cb509a1d3150 | 1 | 2017-10-13 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- POVIDONES
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76413-301 | 76413-301-30 |
| 49348-973 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| POVIDONES | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| a368de95-b5b7-4aa2-bde4-ccca6efb42de | ba4b33b3-e071-4b03-88a0-89dc85f61625 | 2016-03-09 | Warnings | a368de95-b5b7-4aa2-bde4-ccca6efb42de ba4b33b3-e071-4b03-88a0-89dc85f61625 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.