Storage and handling
Other information Store at room temperature
Other information Store at room temperature
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 325 mg
Purposes
Pain reliever/fever reducer
Uses
for the temporary relief of 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 4,000 mg 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
Ask a doctor before use if the user has liver disease.
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.
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)
AGE DOSE
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
do not use for more than 5 days unless directed by a doctor
Children under 6 years ask a doctor
Other information
Store at room temperature
Inactive ingredients
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?Call (800) 616-2471
Do not use if imprinted Safety Seal under cap is broken or missing
Distributed By: MAJOR® PHARMACEUTICALS
17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA
KEEP OUT OF REACH OF CHILDREN
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-857-71 | 2023-10-24 | C162847 | 48780-1 | f386c649-b8bc-0266-e053-dadaa90a7c1a | MAPAP |
| 61919-857-71 | 2023-01-30 | C162847 | 48780-1 | f386c649-b8bc-0266-e053-dadaa90a7c1a | MAPAP |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-857-71 | EA - Each | 61919-857 | e57b2e34-0e48-4913-9e31-3ed152cd3470 | 1 | 2019-08-06 |
| 0904-1982-51 | EA - Each | 0904-1982 | d1f0fa3d-d768-4a49-a185-2ac685e3c890 | 1 | 2013-02-11 |
| 0904-1982-59 | EA - Each | 0904-1982 | a24472eb-cf1e-4286-a017-9b42d265de73 | 1 | 2013-02-11 |
| 0904-1982-60 | EA - Each | 0904-1982 | cf37093b-6a2f-46ec-ace3-b8236093ba0f | 1 | 2013-02-11 |
| 0904-1982-61 | EA - Each | 0904-1982 | 402a4b9b-2be1-45c4-a1d9-316f155ac908 | 1 | 2012-07-24 |
| 0904-1982-80 | EA - Each | 0904-1982 | ea47e96c-011a-4315-be09-7f12254d47fa | 1 | 2013-02-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61919-857 | 61919-857-71 |
| 0904-1982 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K12 | 333AG72FWJ | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
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 |
|---|---|---|---|---|---|---|
| 07497460-3fd6-3d6a-e063-6294a90ad721 | 8eebe866-0aba-79c0-e053-2a95a90a8837 | 2023-10-09 | Warnings | 8eebe866-0aba-79c0-e053-2a95a90a8837 |
Adverse event summaries are temporarily unavailable. Other product information remains available.