Indications and uses
temporarily relieves 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
APAP
- Manufacturer
- Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
- Effective date
- 2017-10-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:52:50
Label at a glance#
ProductAPAP
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
Do not take more than directed (see over dose warning) adults & children 12 years and over : take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years : ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
(in each caplet)
Acetaminophen 500 mg
Purpose
Pain Reliever / Fever Reducer
Uses
temporarily relieves 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. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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 drinks every day while using this product
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 the you have liver disease
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
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: 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 symptoms.
Directions
- Do not take more than directed (see over dose warning) adults & children 12 years and over :
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years : ask a doctor
Other Information
- store at 15-30 °C (59-86 °F)
Inactive Ingredients
polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
Questions or Comments
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 54738-540-01 ..100 APAP 500mg tabs
NDC: 54738-540-03 ..1000 APAP 500mg tabs
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0054738540017 | GTIN-13: 0054738540017 EAN-13: 0054738540017 GTIN-12: 054738540017 UPC-A: 054738540017 GTIN storage (14 digits): 00054738540017 | IMG_4679.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54738-540-01 | APAP | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 54738-540-03 | APAP | 1000 in 1 BOTTLE | TABLET | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54738-540-01 | EA - Each | 54738-540 | 5d17bebf-d9ce-4648-ac1c-3156f3557b65 | 1 | 2017-11-06 |
| 54738-540-03 | EA - Each | 54738-540 | 7f3b9ccd-bcb5-4454-91b1-d48c68cead9d | 1 | 2017-11-06 |
Products#
Every source-derived product name is available through these pages.
- APAP
- Acetaminophen
- POVIDONE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54738-540 | 54738-540-01, 54738-540-03 |
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 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 |
|---|---|---|---|---|---|---|
| APAP | ACETAMINOPHEN | Richmond Pharmaceuticals, Inc. | ad087586-67cd-4875-b0e6-3fba06ea0f65 | 2017-10-30 | Warnings | 54738-540-03 54738-540-01 54738-540 54738054001 54738054003 5cc3aaa6-e1aa-a116-e053-2991aa0a1422 ad087586-67cd-4875-b0e6-3fba06ea0f65 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.