Indications and uses
temporary relief of minor aches and pains associated with: headache backache muscular aches minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Acetaminophen 325mg
- Manufacturer
- McKesson Corporation dba SKY Packaging | Legacy Pharmaceutical Packaging, LLC
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:45:01
Label at a glance#
ProductAcetaminophen 325mg RS
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
Adults and children 12 years of age and over: Take 2 tablets every 4 to 6 hours. Do not take more than 10 tablets in 24 hours. Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours. Children under 6 years of age: Do not use this regular strenght product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each tablet)
Acetaminophen 325mg
Purpose
Pain reliever/fever reducer
Uses
temporary relief of minor aches and pains associated with:
- headache
- backache
- muscular aches
- 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
- 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
- if you are allergic to acetamiophen
- with other products containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if 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
- symptoms do not improve
- pain gets worse or lasts for more than 10 days
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- a rare sensitivity reaction occurs
- You may report side effects to 1-888-952-0050
If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Adults and children 12 years of age and over: Take 2 tablets every 4 to 6 hours.
Do not take more than 10 tablets in 24 hours.
Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.
Do not take more than 5 tablets in 24 hours.
Children under 6 years of age: Do not use this regular strenght product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Other information
- store at room temperature
- do not use if imprinted safety seal under cap is broken or missing
Inactive ingredients
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63739-087-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5cc2-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-087-02 | EA - Each | 63739-087 | 41b7f8df-fc13-437d-8b7d-01b984df41d8 | 1 | 2021-09-07 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen 325mg RS
- Acetaminophen 325mg
- STARCH, CORN
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63739-087 | 63739-087-02 |
| 69168-010 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | 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 |
|---|---|---|---|---|---|---|
| 29b5c498-17e0-c872-e063-6394a90a80e7 | c6f41729-840e-0db5-e053-2a95a90aea7e | 2024-12-20 | Warnings | 29b5c498-17e0-c872-e063-6394a90a80e7 c6f41729-840e-0db5-e053-2a95a90aea7e | ||
| Acetaminophen 325mg RS | ACETAMINOPHEN 325MG | Allegiant Health | 61c6d281-e59b-4277-bbce-f71c12c2a56d | 2019-01-07 | Warnings | 69168-010 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.