Clear Choice Regular Strength Pain Reliever

Manufacturer
Athlete's Needs, Inc.
Effective date
2018-12-11
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:36:16

Label at a glance#

ProductClear Choice Regular Strength Pain Reliever
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and uses

temporary relief of minor aches and pains associated with the common cold headache toothache muscular aches backache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not take more than 10 tablets in 24 hours  Children 6 to 11 years of age: Take 1 tablet every 4 to 6 hours as needed Do not take more than 5 tablets in 24 hours Children under 6 years of age: Do not use this regular strenght product. this will provide more than the recommended dose (overdose) and could cause serious heal...

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Uses

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pains associated with

  • the common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen, Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks ever day while using this product

Allergy alert: Acetaminophen may cause sever 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.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

user has liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

the user is 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
  • pain gets worse or lasts more than 5 days in children under 12
  • 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

ask a health professional before use.             

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

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

Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

Take 2 tablets every 4 to 6 hours as needed.

Do not take more than 10 tablets in 24 hours 

Children 6 to 11 years of age: Take 1 tablet every 4 to 6 hours as needed

Do not take more than 5 tablets in 24 hours

Children under 6 years of age:

Do not use this regular strenght product. this will provide more than the recommended dose (overdose) and could cause serious health problems

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clear Choice

Regular Strength

PAIN RELIEVER

ACETAMINOPHEN

PAIN & FEVER RELIEF

CONTAINS NO ASPIRIN

CAFFEINE FREE

Compare to Regular Strength Tylenol (R)

100 Tablets

325 mg Each

Questions?
Contact A.N.I. 6029 Renaissance Place, Toledo OH 43623
Manufactured for A.N.I.

Pain Reliever
Pain Reliever

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN9
313782acetaminophen 325 MG Oral TabletSCD9
313782APAP 325 MG Oral TabletSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53185-005-00Clear Choice Regular Strength Pain Reliever100 in 1 BOTTLETABLET1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53185-005CLEAR CHOICE REGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS, INC.]9Current NDC, Legacy NDC, 1 package rows20241109_d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53185-00553185-005-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
ndc (package): 53185-005-00
ndc (product): 53185-005
ndc11 (package): 53185000500
spl id: 07a99067-4ec1-49f8-8982-620e6efb78c5
spl set id: d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7

Reported adverse events (FAERS/openFDA)#

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