Acetaminophen - Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd

Manufacturer
Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-06 02:04:46

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections

Indications and uses

To reduce fever and for the temporary relief of minor aches and pains due to: headache  muscular aches backache minor pain from arthritis  the common cold toothache premenstrual and menstrual cramps temporarily reduces fever.

Dosage and administration

Do not take more than directed 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. do not take for more than 10 days unless directed by a doctor Children 6 years to under 12 years: 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 b...

Label contents#

Full prescribing information#

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)                          Purpose
Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

To reduce fever and for the temporary relief of minor aches and
pains due to:

  • headache 
  • muscular aches
  • backache
  • minor pain from arthritis 
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever.

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 10 tablets in 24 hours, which is the maximum daily amount 
  • child takes more than 5 tablets 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

OTC - DO NOT USE SECTION

  • 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.
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 days in adults and children.
• pain gets worse or lasts more than 5 days in children under 12 years.
• 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:
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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed
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.
  • do not take for more than 10 days unless directed by a doctor

Children 6 years to under 12 years:

  • 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

  • SODIUM FREE
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • see end panel for lot number and expiration date.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.

OTC - QUESTIONS SECTION

Questions and Comments? Call 1-844-474-7464

†This product is neither manufactured nor distributed by the owner of the registered trademark Tylenol® Regular strength.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/2258

Revised: 06/2026 (S-065-01)

Revised: 06/2026 (S-069-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen

325 mg

100 Film Coated Tablets

acetaminophen-325mg-100ctacetaminophen-325mg-100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen

325 mg

1000 Film Coated Tablets

acetaminophen-325mg-1000ctacetaminophen-325mg-1000ct

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357237346105GTIN-13: 0357237346105
EAN-13: 0357237346105
GTIN-12: 357237346105
UPC-A: 357237346105
GTIN storage (14 digits): 00357237346105
acetaminophen-325mg-1000ct.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-346-01EA - Each57237-3462ccb0212-ce31-48f1-bb7c-e48bd05936bd12025-08-11
57237-346-10EA - Each57237-34639d36403-64f2-4dbf-ad05-c27fd026367a12025-11-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-34657237-346-01, 57237-346-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-07-22full-release2026-06-01 01:08:39

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d8c82e39-36b4-4077-8485-645aea17e404bd5e6804-4df4-4a65-92e4-faa3a0f7c0052025-07-22WarningsExact identifier
spl set id: bd5e6804-4df4-4a65-92e4-faa3a0f7c005

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.