Acetaminophen 325 Mg

Acetaminophen 325 Mg
SPL v26
SPL
SPL Set ID 04805d9c-d959-4870-a185-48b58a880880
Route
ORAL
Published
Effective Date 2023-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hypromellose, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid Polyethylene Glycol, Unspecified Povidone K30 Starch, Corn Hypromelloses Polyethylene Glycol Povidone Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G323 Shape: round Color: white Size: 9 mm Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-27 Until 2022-12-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 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.

Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

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

temporarily reduces fever

Dosage and Administration

Directions

  • do not use 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, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

Children under 12 years:

  • ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop using and ask a doctor if

  • pain gets worse and lasts for more than 10 days
  • 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

Section 50568-5

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
Section 50570-1

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
Section 51727-6

Inactive ingredients

corn starch*, hypromellose, polyethylene glycol, povidone (K-30)*, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide*

May contain*

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 325 mg

Section 60561-8

Other information

  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Medique Apap

Medique ®

APAP

Non-Aspirin Tablets

Tabletas sin aspirina

Pain Reliever/Fever Reducer • Acetaminophen 325 mg

Alivia el Dolor/Reduce la Fiebre • Acetaminofeno 325 mg

This Package is For Households Without young Children

Este Paquete es Para Hogares sin Ninos Pequenos

Pull to Open

Tira Para Abrir

500 Tablets

(250 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

Dover Aminofen

Dover Aminofen

Acetaminophen 325 MG

Pain Reliever-Fever Reducer

This Package is for Households withoutn Young Children.

Dover Pharmaceutical

Products of the highest quality and effectiveness

Tamper Evident

Sealed Packets

Unit Dose Packs

500 Tablets

(250 Packets of 2)

All Dover Pharmaceutical formulas conform to federal regulations

Antihistamine free

No danger of drowsiness

Sugar Free

​for safer use by diabetics

Salt free

​Minimizes high blood pressure

Caffeine Free

​Avoides over stimulation

Medi First Non Aspirin

Medi-First ®

Non-Aspirin

Pain Reliever/Fever Reducer

Aches, Fever ● Acetaminophen 325 mg

Compare active ingredient to:

Tylenol®

This Package is For Households Without Young Children

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2)

Medi First Plus Non Aspirin

Medi First ® Plus

Non-Aspirin

Acetaminophen 325mg

Pull to Open

This Package is For Households Without Young Children

Pain Reliever/Fever Reducer

Compare active ingredient to:

Tylenol®

Registered Trademark of McNeil Consumer

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2's)


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

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

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

  • do not use 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, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

Children under 12 years:

  • ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop using and ask a doctor if

  • pain gets worse and lasts for more than 10 days
  • 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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

corn starch*, hypromellose, polyethylene glycol, povidone (K-30)*, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide*

May contain*

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 325 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Medique Apap

Medique ®

APAP

Non-Aspirin Tablets

Tabletas sin aspirina

Pain Reliever/Fever Reducer • Acetaminophen 325 mg

Alivia el Dolor/Reduce la Fiebre • Acetaminofeno 325 mg

This Package is For Households Without young Children

Este Paquete es Para Hogares sin Ninos Pequenos

Pull to Open

Tira Para Abrir

500 Tablets

(250 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

Dover Aminofen

Dover Aminofen

Acetaminophen 325 MG

Pain Reliever-Fever Reducer

This Package is for Households withoutn Young Children.

Dover Pharmaceutical

Products of the highest quality and effectiveness

Tamper Evident

Sealed Packets

Unit Dose Packs

500 Tablets

(250 Packets of 2)

All Dover Pharmaceutical formulas conform to federal regulations

Antihistamine free

No danger of drowsiness

Sugar Free

​for safer use by diabetics

Salt free

​Minimizes high blood pressure

Caffeine Free

​Avoides over stimulation

Medi First Non Aspirin (Medi-First Non Aspirin)

Medi-First ®

Non-Aspirin

Pain Reliever/Fever Reducer

Aches, Fever ● Acetaminophen 325 mg

Compare active ingredient to:

Tylenol®

This Package is For Households Without Young Children

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2)

Medi First Plus Non Aspirin (Medi-First Plus Non Aspirin)

Medi First ® Plus

Non-Aspirin

Acetaminophen 325mg

Pull to Open

This Package is For Households Without Young Children

Pain Reliever/Fever Reducer

Compare active ingredient to:

Tylenol®

Registered Trademark of McNeil Consumer

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2's)


Advanced Ingredient Data


Raw Label Data

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