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
- Allegiant Health
- Effective date
- 2019-01-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:59:33
Label at a glance#
ProductAcetaminophen 325mg RS
Active ingredientAcetaminophen
Label structure9 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 6-11 years of age: Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours. Do not us...
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. 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
- adult takes more than 4,000mg 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 non-prescription). 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 user has
liver disease.
Ask a doctor or pharmacist before use if
- the user is taking the blood thinning drug warfarin
- is a child with pain of arthritis
Stop use and ask a doctor if
- Adult’s pain gets worse or lasts more than 10 days
- Child’s pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
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 (1-800-222-1222) right away.
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:
- 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 6-11 years of age:
- 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 20°– 25°C (68°– 77°F)
- 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
Questions or Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-010-30 | Acetaminophen 325mgRS | 30 in 1 BOTTLE | TABLET | 30 | 4 | |
| 69168-010-30 | Acetaminophen 325mgRS | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 69168-010-50 | Acetaminophen 325mgRS | 50 in 1 BOTTLE | TABLET | 50 | 4 | |
| 69168-010-50 | Acetaminophen 325mgRS | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 69168-010-60 | Acetaminophen 325mgRS | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 69168-010-60 | Acetaminophen 325mgRS | 60 in 1 BOTTLE | TABLET | 60 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen 325mg RS
- Acetaminophen 325mg
- Acetaminophen
- STARCH, CORN
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69168-010 | 69168-010-60, 69168-010-50, 69168-010-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|
| Acetaminophen 325mg RS | ACETAMINOPHEN 325MG | Allegiant Health | 61c6d281-e59b-4277-bbce-f71c12c2a56d | 2019-01-07 | Warnings | 69168-010-50 69168-010-60 69168-010-30 69168-010 69168001030 69168001050 69168001060 92f2ab65-26c5-4e2e-9f13-1d7836c8d559 61c6d281-e59b-4277-bbce-f71c12c2a56d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.