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
acetaminophen
- Manufacturer
- Safrel Pharmaceuticals, LLC.
- Effective date
- 2021-06-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:40:47
Label at a glance#
Productacetaminophen
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 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Storage and handling
store at 20-25 ° C (68-77 ° F)
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. 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
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 have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if 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
- 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)
adults and children 12 years and over |
|
children under 12 years | ask a doctor |
Other information
- store at 20-25 °C (68-77 °F)
Inactive ingredients
carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
1--844-384-3723
Package/Label Principal Display Panel
Compare to the active ingredient in Tylenol ® Rapid Release Gels
Rapid Release Caplets
EXTRA STRENGTH
Acetaminophen Caplets, 500 mg
Pain reliever;
Fever reducer
Aspirin free
For Adults
RAPID RELEASE
DYE FREE
400 Count
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71309-077-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-50fb-111a-e063-dadaa90a10e2 | Acetaminophen Rapid Release Caplets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71309-077-04 | acetaminophen | 400 in 1 BOTTLE | TABLET, FILM COATED | 400 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- acetaminophen
- STARCH, CORN
- CARNAUBA WAX
- HYPROMELLOSE, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STEARIC ACID
- SODIUM STARCH GLYCOLATE TYPE A CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71309-077 | 71309-077-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | 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 |
|---|---|---|---|---|---|---|
| c4803357-0458-8a9d-e053-2995a90a102c | a2d4238e-1498-4379-e053-2995a90a318f | 2021-06-11 | Warnings | c4803357-0458-8a9d-e053-2995a90a102c a2d4238e-1498-4379-e053-2995a90a318f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.