FDA.reportPublic FDA data

Pain Relief Easy to Swallow

Manufacturer
Allegiant Health
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:39:19

Label at a glance#

ProductPain Relief Easy to Swallow Extra Strength Easy to Swallow
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporary relief of minor aches and pains associated with common cold headache toothache muscular aches backache arthritis menstrual cramps and reduction of fever

Dosage and administration

do not use more than directed (see overdose warning) adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours. Do not use more than 10 days unless directed by a doctor children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of minor aches and pains associated with
  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
  • and reduction of fever

Warnings

WARNINGS SECTION

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

  • more than 4000 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

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

OTC - DO NOT USE SECTION

  • if you are allergic to acetaminophen
  • 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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs
  • You may report side effects to 1-888-952-0050

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 (1-800-222-1222) 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 use more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
  • Do not use more than 10 days unless directed by a doctor
  • children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, FD&C red#40 aluminum lake, hypromellose, polyethylene glycol 400, polyethylene glycol 8000, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, sucralose, titanium dioxide

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen 500 mg
Acetaminophen 500 mg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-353-992020-03-13C16284748780-19d75b9d1-23af-f424-e053-dadaa90a57ceDrug Facts
69168-353-992020-01-31C16284748780-19d75b9d1-23af-f424-e053-dadaa90a57ceDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-35369168-353-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSES3NXW29V3WOIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
f6e80ada-ffdc-453e-8fe7-2f081b8868a53329f052-a069-4a36-a3be-882f55a0f8312018-12-26WarningsExact identifier
spl set id: 3329f052-a069-4a36-a3be-882f55a0f831

Reported adverse events (FAERS/openFDA)#

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