Meijer Distribution, Inc. Pain Relief Drug Facts

Meijer Distribution, Inc. Pain Relief Drug Facts
SPL v3
SPL
SPL Set ID 43c3fe72-a4ef-48a6-bc22-a644919c0c5c
Route
ORAL
Published
Effective Date 2024-06-17
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 2024-06-17

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:
  • the common cold
  • headache
  • minor pain of arthritis
  • backache
  • muscular aches
  • 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?

1-800-719-9260

Principal Display Panel

meijer®

REGULAR STRENGTH

Pain Relief

COMPARE TO TYLENOL® ACTIVE INGREDIENT

ACETAMINOPHEN

PAIN RELIEVER | FEVER REDUCER

For Ages 6 Years And Over

Actual Size

100 TABLETS

325 mg each

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

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:
  • the common cold
  • headache
  • minor pain of arthritis
  • backache
  • muscular aches
  • 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?)

1-800-719-9260

Principal Display Panel

meijer®

REGULAR STRENGTH

Pain Relief

COMPARE TO TYLENOL® ACTIVE INGREDIENT

ACETAMINOPHEN

PAIN RELIEVER | FEVER REDUCER

For Ages 6 Years And Over

Actual Size

100 TABLETS

325 mg each

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

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

All Sections (JSON)