Acetaminophen Extra Strength

Manufacturer
Family Dollar Stores, LLC | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:35

Label at a glance#

ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

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° to 25°C (68° to 77°F). Avoid high humidity do not use if carton is open. Do not use if printed foil seal under cap is torn or missing

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of 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 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

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

  • 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity
  • do not use if carton is open. Do not use if printed foil seal under cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-855-274-4122

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY
Wellness ™

EXTRA STRENGTH
PAIN RELIEF
Acetaminophen Gelcaps
500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels

FOR ADULTS

100 GELCAPS
500 mg Each                    NDC 55319-053-21



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY
Wellness ™

COMPARE TO THE ACTIVE
INGREDIENT IN EXTRA STRENGTH
TYLENOL RAPID RELEASE GELS*

EXTRA STRENGTH
PAIN RELIEF                                                RAPID
                                                                         RELEASE
Acetaminophen Gelcaps, 500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels

FOR ADULTS                                                
ACTUAL SIZE

100 GELCAPS                DO NOT USE WITH OTHER MEDICINES
500 mg Each                      CONTAINING ACETAMINOPHEN                            NDC 55319-053-21



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
198440acetaminophen 500 MG Oral TabletSCD3
198440APAP 500 MG Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-053-14Acetaminophen Extra Strength50 in 1 BOTTLETABLET503
55319-053-14Acetaminophen Extra Strength1 in 1 CARTONTABLET13
55319-053-21Acetaminophen Extra Strength100 in 1 BOTTLETABLET1003
55319-053-21Acetaminophen Extra Strength1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-053ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR STORES, LLC]3Current NDC, 4 package rows20231207_f86dcbb8-debc-4bce-e053-6294a90a7a02.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-05355319-053-14, 55319-053-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
ndc (package): 55319-053-21
ndc (package): 55319-053-14
ndc (product): 55319-053
ndc11 (package): 55319005314
ndc11 (package): 55319005321
spl id: 0bd0c0ce-b9a6-c10e-e063-6394a90a3c77
spl set id: f86dcbb8-debc-4bce-e053-6294a90a7a02

Reported adverse events (FAERS/openFDA)#

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