Clear Choice Regular Strength Pain Reliever

Clear Choice Regular Strength Pain Reliever
SPL v9
SPL
SPL Set ID d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7
Route
ORAL
Published
Effective Date 2018-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Starch, Corn Hypromelloses Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide Povidone Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: AZ234 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-03

Description

Acetaminophen 325 mg

Purpose

Pain reliever / fever reducer


Medication Information

Purpose

Pain reliever / fever reducer

Description

Acetaminophen 325 mg

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

Purposes

Pain reliever / fever reducer

Warnings

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.

Directions

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

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.

Package Label

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

Inactive Ingredients

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

Ask A Doctor Before Use If

user has liver disease

Stop Use and Ask A Doctor If
  • 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,

ask a health professional before use.             

Keep Out of Reach of Children.

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.

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Ask A Doctor Or Pharmacist Before Use If

the user is taking the blood thinning drug warfarin


Structured Label Content

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

Purposes

Pain reliever / fever reducer

Warnings

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.

Directions

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

Do Not Use (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.

Package Label

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
Other Information (Other 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 ingredients)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

user has liver disease

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.             

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Acetaminophen 325 mg

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

the user is taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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