Regular Strength Pain Reliever

Manufacturer
Healthlife of USA | Time Cap Laboratories, Inc.
Effective date
2017-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:06:12

Label at a glance#

ProductRegular Strength Pain Reliever
Active ingredientACETAMINOPHEN
Label structure15 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning) Adults and Children 12 years of age and over: take 2 tablets every 4 to 6 hours while symptoms last do not take  more than 9 tablets in 24 hours period do not use for more  than 10 days unless directed by doctor Children 6 to 12 years: take 1 tablet every 4 to 6 hours while symptoms last do not use more than 5 tablets in 24 hours period children under 6 years a...

Label contents#

Full prescribing information#

Active Ingredient (In each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

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
  • temporarily reduces fever 
  • premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

Liver Warning:

This product contains acetaminophen. The maximum daily dose of this product is 9 tablets (2925 mg) in 24 hours. Severe liver damage may occur if you take:

  • more than 3000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash 

If 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 not prescription). 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 doctor before use if you have 

OTC - ASK DOCTOR SECTION

liver disease

Ask your 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.

Overdose warning:

SPL UNCLASSIFIED SECTION

Taking more than 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 take more than directed (see overdose warning)

Adults and Children 12 years of age and over:

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take  more than 9 tablets in 24 hours period
  • do not use for more  than 10 days unless directed by doctor

Children 6 to 12 years: take 1 tablet every 4 to 6 hours while symptoms last

  • do not use more than 5 tablets in 24 hours period
  • children under 6 years ask doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • 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

Call toll free 1-844-832-1138 Monday through Friday 9AM-5PM EST or www.healthlifeofusa.com

Principal Display Panel Regular Strength Pain RelieverAcetaminophen 325mg- Pain Reliever/ Fever Reducer30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-123-302024-06-13C16284748780-19d75b9d0-f2ce-f424-e053-dadaa90a57cePain Reliever Regular Strength
69517-123-302020-01-31C16284748780-19d75b9d0-f2ce-f424-e053-dadaa90a57cePain Reliever Regular Strength

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-12369517-123-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

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
085b7ce1-fa07-470c-e063-6294a90a162bfafa1c47-2ba7-4a4d-8db2-66eed89621d42024-06-13WarningsExact identifier
spl set id: fafa1c47-2ba7-4a4d-8db2-66eed89621d4

Reported adverse events (FAERS/openFDA)#

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