Acetaminophen 325mg

Acetaminophen 325mg
SPL v3
SPL
SPL Set ID c26f1872-ebff-4164-bf64-4272df43a2db
Route
ORAL
Published
Effective Date 2019-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Form Stearic Acid Povidone, Unspecified Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: MLX123 Shape: round Color: white Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-01

Description

Drug Facts

Purpose

Pain Reliever/ Fever Reducer


Medication Information

Purpose

Pain Reliever/ Fever Reducer

Description

Drug Facts

Uses

Temporary relieves minor aches and pains due to:

  • The common cold

  • Headache

  • Backache

  • Minor pain of arthritis

  • Toothache

  • Muscular aches

  • Premenstrual and menstrual cramps

* Temporarily reduces fever.

Section 42229-5

Drug Facts

Warnings

Liver warning : this product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours

  • with other drugs containing acetaminophen

  • 3 or more alcoholic drinks every day while using this product
Directions

Do not take m ore than directed (see overdose warning )

Adults and Children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.

  • Do not take more than 12 tablets in 24 hours, unless directed by a doctor.

  • 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.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product.

Drug Facts (continued)

Ask a doctor before use if you have liver disease .

Active Ingredient

Acetaminophen USP 325 mg

Ask A Doctor Or P

if you are taking th e blood thinning drug warfarin.

Other Information
  • Store between 20-25 ˚C (68-77 ˚F).

  • See end panel for lot number and expiration date.
Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Carboxymethyl Starch, Stearic Acid

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Principal Display Panel

NDC 10135-0123-01

Acetaminophen

325 mg


100 TABLETS

Stop Use and Ask A Doctor If
  • 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,

ask a health professional before use.


Structured Label Content

Uses

Temporary relieves minor aches and pains due to:

  • The common cold

  • Headache

  • Backache

  • Minor pain of arthritis

  • Toothache

  • Muscular aches

  • Premenstrual and menstrual cramps

* Temporarily reduces fever.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain Reliever/ Fever Reducer

Warnings

Liver warning : this product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours

  • with other drugs containing acetaminophen

  • 3 or more alcoholic drinks every day while using this product
Directions

Do not take m ore than directed (see overdose warning )

Adults and Children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.

  • Do not take more than 12 tablets in 24 hours, unless directed by a doctor.

  • 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.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product.

Drug Facts (continued)

Ask a doctor before use if you have liver disease .

Active Ingredient

Acetaminophen USP 325 mg

Ask A Doctor Or P (Ask a doctor or p)

if you are taking th e blood thinning drug warfarin.

Other Information
  • Store between 20-25 ˚C (68-77 ˚F).

  • See end panel for lot number and expiration date.
Overdose Warning: (Overdose warning:)

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Carboxymethyl Starch, Stearic Acid

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0123-01

Acetaminophen

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.

  • 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)