Wal-mart Pain Reliever Drug Facts

Wal-mart Pain Reliever Drug Facts
SPL v2
SPL
SPL Set ID 4518fe82-3ba8-4e9e-a036-776df7fb8d57
Route
ORAL
Published
Effective Date 2024-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Croscarmellose Sodium Povidone, Unspecified Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 325MG;L403 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-21

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

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
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 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.

Directions
  • do not take more than directed (see overdose warning)

adults and children 12 years and over

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

children

6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a
  •  
    doctor

children under

6 years

ask a doctor

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 the user has ever had an allergic reaction to this product or any of its ingredients
Inactive Ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient

Questions Or Comments?

1-888-287-1915

Principal Display Panel

equate™

Compare to Regular Strength Tylenol® Tablets active ingredient

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/Fever Reducer

Actual Size

325 mg

100 TABLETS

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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,

ask a health professional before use.

Keep Out of Reach of Children.

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.

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Ask A Doctor Before Use If the User
  • has liver disease
  • is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin


Structured Label Content

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
Purpose

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 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.

Directions
  • do not take more than directed (see overdose warning)

adults and children 12 years and over

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

children

6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a
  •  
    doctor

children under

6 years

ask a doctor

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.
  • if the user has ever had an allergic reaction to this product or any of its ingredients
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel

equate™

Compare to Regular Strength Tylenol® Tablets active ingredient

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/Fever Reducer

Actual Size

325 mg

100 TABLETS

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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.

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

Acetaminophen 325 mg

Ask A Doctor Before Use If the User (Ask a doctor before use if the user)
  • has liver disease
  • is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If the User Is (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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