RELORN ACETAMINOPHEN TABLETS, USP 500 mg

Manufacturer
UNIPHARM, INC.
Effective date
2020-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:39:00

Label at a glance#

ProductRELORN
Active ingredientACETAMINOPHEN
Label structure21 sections

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

Dosage and administration

do not take more than directed (see Overdose warning) adults & children 12 years and over: take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets 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 - 25ºC (68 - 77ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet):

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, 500 mg

Aspirin and Caffeine Free

Purpose:

OTC - PURPOSE SECTION

Pain reliever/fever reducer

SPL UNCLASSIFIED SECTION

Compare to Active Ingredient in Tylenol® Extra Strength Tablets.

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark ExtraStrength TYLENOL®.

Uses:

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Overdose warning:

SPL UNCLASSIFIED SECTION

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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other safety Information:

OTHER SAFETY INFORMATION

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.

OTC - DO NOT USE SECTION

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 acetaminophen or any of the inactive ingredients in this product.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask your doctor or pharmacist before use:

  • if you have liver disease   
  • if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use:  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.

Pregnancy or breast feeding:

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

Directions:

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see Overdose warning)

adults & children 12 years and over:

  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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

Other information:

STORAGE AND HANDLING SECTION

Store at 20 - 25ºC (68 - 77ºF)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Each tablet contains 0.22 mg of Sodium.

Questions or comments?

OTC - QUESTIONS SECTION

1-212-594-3260, 9:00 am – 5:00 pm EST, Monday-Friday

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing.

LB-5427-06EN 200305V1.1

SPL UNCLASSIFIED SECTION

Tested by Ameripharma Labs, LLC, Somerset, NJ, 08873

Packaged by Unipharm, Inc., Waterbury, CT, 06705

Distributed by Unipharm, Inc., New York, NY, 10118

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62900-542-602024-02-22C16284748780-1d6a99b39-d5c4-a426-e053-dadaa90af4c2RELORN ACETAMINOPHEN TABLETS, USP 500 mg
62900-542-602022-01-28C16284748780-1d6a99b39-d5c4-a426-e053-dadaa90af4c2RELORN ACETAMINOPHEN TABLETS, USP 500 mg

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
62900-54262900-542-60

Ingredients#

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

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

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
10b9cfe0-7e1a-780e-e063-6394a90ab4efd59f71a2-994a-4e55-a3d5-f71815372a4a2024-02-06WarningsExact identifier
spl set id: d59f71a2-994a-4e55-a3d5-f71815372a4a

Reported adverse events (FAERS/openFDA)#

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