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
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:41:43
Label at a glance#
ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure19 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, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours ...
Storage and handling
store between 20-25°C (68-77°F) do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing
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
SPL UNCLASSIFIED SECTION
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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 drugs 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 you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
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 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 years to under 12 years |
|
| children under 6 years | ask a doctor |
Other information
- store between 20-25°C (68-77°F)
- do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
Distributed By
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL - 100 Tablets bottle
VALUMEDS
Compare to the active ingredient in
Regular Strength Tylenol®*
REGULAR STRENGTH
PAIN
RELIEF
ACETAMINOPHEN 325 mg
PAIN RELIVER/
FEVER REDUCER
100 TABLETS
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-0022-1 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-0022 | ACETAMINOPHEN TABLET [SPIRIT PHARMACEUTICALS LLC] | 8 | Legacy NDC, 1 package rows | 20241211_e36a4e7b-c4a3-498c-81bd-ca8e1a3e120b.zip |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN
- POVIDONE
- STARCH, PREGELATINIZED CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-0022 | 68210-0022-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 28dbb15c-44d4-ee5f-e063-6294a90a6433 | e36a4e7b-c4a3-498c-81bd-ca8e1a3e120b | 2024-12-09 | Warnings | 28dbb15c-44d4-ee5f-e063-6294a90a6433 e36a4e7b-c4a3-498c-81bd-ca8e1a3e120b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.