FDA.reportPublic FDA data

Regular Strength Pain Relief

Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-05
Label type
HUMAN OTC DRUG LABEL
Version
103
Source
legacy-cache
Hydrated at
2026-08-01 20:59:36

Label at a glance#

ProductRegular Strength Pain Relief
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over: Take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor. children under 12 years: ask a doctor

Storage and handling

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at 20⁰C-25⁰C (68⁰F-77⁰F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg (12 tablets) 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.

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 symptom 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • adults and children 12 years and over: Take 2 tablets every 4-6 hours,
    as needed; not more than 10 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
  • children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

povidone, sodium starch glycolate, starch, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

HOW SUPPLIED

How Supplied Section

Acetaminophen 325 mg Tablet

  • NDC: 71335-1847-1: 20 Tablets in a BOTTLE
  • NDC: 71335-1847-2: 100 Tablets in a BOTTLE
  • NDC: 71335-1847-3: 30 Tablets in a BOTTLE
  • NDC: 71335-1847-4: 2 Tablets in a BOTTLE
  • NDC: 71335-1847-5: 6 Tablets in a BOTTLE
  • NDC: 71335-1847-6: 10 Tablets in a BOTTLE
  • NDC: 71335-1847-7: 60 Tablets in a BOTTLE
  • NDC: 71335-1847-8: 90 Tablets in a BOTTLE
  • NDC: 71335-1847-9: 40 Tablets in a BOTTLE
  • NDC: 71335-1847-0: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen 325 mg Tablet

Label
Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1847REGULAR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]103Legacy NDC20240707_84319ef4-96b2-41d4-b094-844902a86098.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1847-1EA - Each71335-184703559d03-d4ae-4ec7-8b32-3caaa202d89612023-01-09
71335-1847-2EA - Each71335-184752c2ce54-c8e3-4035-9709-7428862afa5712023-01-09
71335-1847-3EA - Each71335-1847259c3db0-6807-47bf-aa50-1a5b7824ffa212023-01-09
71335-1847-9EA - Each71335-1847db49f272-e0a2-41f3-a030-6d75ade9dcbf12023-01-09
57896-104-01EA - Each57896-1049c729477-9f92-45a4-9237-ba204105dab912023-06-06
57896-104-10EA - Each57896-104912af808-5ba7-4a40-9353-9a868e25569d12021-05-05
57896-104-20EA - Each57896-104cd916e63-66db-4bb5-97b2-9c366aee75d612021-11-09

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-184771335-1847-1, 71335-1847-2, 71335-1847-3, 71335-1847-4, 71335-1847-5, 71335-1847-6, 71335-1847-7, 71335-1847-8, 71335-1847-9, 71335-1847-0
57896-104

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

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
5d03c2f6-427e-4140-911f-c8f6cc03fa4784319ef4-96b2-41d4-b094-844902a860982026-04-27WarningsExact identifier
spl set id: 84319ef4-96b2-41d4-b094-844902a86098

Reported adverse events (FAERS/openFDA)#

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