Indications and uses
for the temporary relief of minor aches and pains due to: Headache Muscular aches Backache Toothache Premenstrual and menstrual cramps Temporally reduces fever.
Acetaminophen
- Manufacturer
- Southern Sales & Service, Inc.
- Effective date
- 2023-11-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:03:02
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections
Dosage and administration
Directions Adults and Children 12 years and older Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6 to 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 regular Strength products in children uder 6 years of age; this will provide more than the recommended dose...
Label contents#
Full prescribing information#
Active Ingredient (in each Tablet)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
for the temporary relief of minor aches and pains due to:
Headache
Muscular aches
Backache
Toothache
Premenstrual and menstrual cramps
Temporally reduces fever.
• Liver warning Warnings
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
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription)
- 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 under 12 years
Fever gets worse or last 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 doctor before use.
Keep out of the 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or syptoms.
- Do not take more tahn directed (see overdose warning)
Directions
Adults and Children 12 years and older | Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours |
Children 6 to 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 regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. |
Other information
store at room temperature 20°-25°C (68-77°F)
Inactive Ingredients
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid
Acetaminophen 100 tablet
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69822-692-10 | Acetaminophen | 325 in 1 BOTTLE | TABLET | 325 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1327-01 | EA - Each | 0536-1327 | 60f916f6-73b9-4c6b-84aa-b3e4bcd1b6dd | 1 | 2021-05-05 |
| 0536-1327-06 | EA - Each | 0536-1327 | ea9dcedd-e2b7-4c82-a80d-03aaa79a8a8d | 1 | 2021-05-05 |
| 0536-1327-10 | EA - Each | 0536-1327 | db6e0748-a65f-4711-908e-7c22c9c439b0 | 1 | 2021-05-05 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69822-692 | 69822-692-10 |
| 0536-1327 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|
| Rugby Regular Strength Acetaminophen | ACETAMINOPHEN | RUGBY LABORATORIES | 295b0d00-4d4a-405f-9325-d01c5d4f3ed4 | 2024-12-20 | Warnings | 0536-1327 |
| 0b57cdc0-3b62-26fd-e063-6394a90ad4fa | 8b838af4-a74d-47b4-952e-dcf5598b08e1 | 2023-11-29 | Warnings | 0b57cdc0-3b62-26fd-e063-6394a90ad4fa 8b838af4-a74d-47b4-952e-dcf5598b08e1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.