Extra Strength No-Pain

Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2025-04-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:59:36

Label at a glance#

ProductExtra Strength No-Pain
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

 do not use more than directed (see overdose warning) Adults and children 12 years of age and older: Take 2 caplets every 6 hours while symptoms last. Do not take more than 6 caplets in 24 hours, unless directed by a doctor Do not use more than 10 days unless directed by a doctor. Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporary relieves minor aches and pains due to
  • the common cold
  • headache
  • backache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps and
  • 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

  • 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 this product or any of its ingredients

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 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: Taking more than the reccomended 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.
Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

  •  do not use more than directed (see overdose warning)
  • Adults and children 12 years of age and older:
  • Take 2 caplets every 6 hours while symptoms last.
  • Do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • Do not use more than 10 days unless directed by a doctor.
  • Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

OTHER SAFETY INFORMATION

  • store at controlled room temperature 20-25°C (68-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic Acid, Talc, Titanium Dioxide

Questions or Comments

OTC - QUESTIONS SECTION

1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Tylenol*.

NDC 71309-001-05 500 Caplets

apap 500apap 500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN6
198440acetaminophen 500 MG Oral TabletSCD6
198440APAP 500 MG Oral TabletSY6

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-001-05Extra Strength No-Pain500 in 1 BOTTLETABLET5006
71309-001-40Extra Strength No-Pain40 in 1 BOTTLETABLET406
71309-001-40Extra Strength No-Pain1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-001EXTRA STRENGTH NO-PAIN (ACETAMINOPHEN) TABLET [SAFREL PHARMACEUTICALS, LLC.]6Current NDC, Legacy NDC, 3 package rows20250425_873f01dd-0701-5fd3-e053-2a95a90a6463.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71309-00171309-001-05, 71309-001-40

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

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
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
ndc (package): 71309-001-40
ndc (package): 71309-001-05
ndc (product): 71309-001
ndc11 (package): 71309000140
ndc11 (package): 71309000105
spl id: 3371e8dc-ae55-9a65-e063-6394a90aeaac
spl set id: 873f01dd-0701-5fd3-e053-2a95a90a6463

Reported adverse events (FAERS/openFDA)#

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