Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Acetaminophen Rapid Release
- Manufacturer
- Kinray LLC
- Effective date
- 2019-10-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:07:14
Label at a glance#
ProductAcetaminophen Rapid Release
Active ingredientACETAMINOPHEN
Label structure11 sections
Dosage and administration
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps 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 between 20-25°C (68-77°F) retain carton for complete product information
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each gelcap)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- 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
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 are allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 |
|
Other information
- store between 20-25°C (68-77°F)
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions or comments?
Call 609-288-6060
SPL UNCLASSIFIED SECTION
Distributed by: Kinray LLC., Whitestone, NY 11357
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
NDC 61715-101-51
†Compare to Tylenol® Extra Strength Rapid Release Gels
Preferred
plus
Pharmacy
®
Extra Strength
ACETAMINOPHEN
Pain Reliever/Fever Reducer
SATISFACTION
Preferred
plus
Pharmacy
GUARANTEED
RAPID RELEASE
Fast Relief
100 GELCAPS - 500 mg each
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Rapid Release
- Acetaminophen
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- D&C RED NO. 33
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- FERROSOFERRIC OXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61715-101 | 61715-101-51 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | GEL / TOPICAL | NA | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, CHEWABLE / ORAL | 10 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, DELAYED RELEASE / ORAL | 19 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | SOLUTION / TOPICAL | 200 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAMUSCULAR | 16 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 187.6 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | GEL / TRANSDERMAL | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / RESPIRATORY (INHALATION) | 100 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 14 mg |
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 |
|---|---|---|---|---|---|---|
| 951075e1-cc33-5375-e053-2a95a90a327a | 533f8bf0-4b60-4efe-85ec-d34198d58b81 | 2019-10-16 | Warnings | 951075e1-cc33-5375-e053-2a95a90a327a 533f8bf0-4b60-4efe-85ec-d34198d58b81 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.