Acetaminophen 325 Mg

SPL v3

SPL

SPL Set ID 4c84948d-3a95-4c53-8529-7e7b9d8bb6df

Route

ORAL

Published

Effective Date 2024-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Hypromellose, Unspecified Polyethylene Glycol, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Potato Starch, Corn Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AZ;234 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

For the temporary relief of minor aches and pains associated with

•
headache
•
common cold
•
muscular aches
•
toothache
•
minor arthritis pain
•
menstrual cramps

For the reduction of fever.

Section 42229-5

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

•
more than 12 tablets 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

Directions

•
do not use more than directed

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.
•
for more than 10 days for pain unless directed by a doctor
•
for more than 3 days for fever unless directed by a doctor

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.

Other Information

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

Inactive Ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* may contain

Questions Or Comments?

1-800-634-7680

Children Under 12 Years:

Do not give to children under 12 years of age.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Stop Using and Ask A Doctor If

•
symptoms do not improve
•
new symptoms occur
•
pain or fever persists or gets worse
•
redness or swelling is present

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have

•
liver disease

Medi First Non Aspirin 325 Mg Label

4 Tablets

71205-306-04

Medi-First ^®

Non-Aspirin

Aches, Fever ● Acetaminophen 500mg

Dolores, Fiebre ● Acetaminofeno 500mg

Aspirin-Free Pain Relief

Pull to Open

Tire Para Abrir

Compare active ingredients to:

Compare el ingrediente activo con:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Products

Marca Registrada de McNeil Consumer Products

Tamper Evident Unit Dose Packets

Empaquetado con Sellado

Evidente en Dosis Unitarias

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Ask A Doctor Or Pharmacist Before Use If

•
you are taking the blood thinning drug warfarin

Adults and Children: (12 Years and Older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with

•
headache
•
common cold
•
muscular aches
•
toothache
•
minor arthritis pain
•
menstrual cramps

For the reduction of fever.

Section 42229-5 (42229-5)

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

•
more than 12 tablets 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

Purpose

Pain reliever/fever reducer

Directions

•
do not use more than directed

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.
•
for more than 10 days for pain unless directed by a doctor
•
for more than 3 days for fever unless directed by a doctor

Allergy Alert: (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.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* may contain

Questions Or Comments? (Questions or comments?)

1-800-634-7680

Children Under 12 Years: (Children under 12 years:)

Do not give to children under 12 years of age.

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.)

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)

•
symptoms do not improve
•
new symptoms occur
•
pain or fever persists or gets worse
•
redness or swelling is present

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

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
liver disease

Medi First Non Aspirin 325 Mg Label (Medi-First Non-Aspirin 325 mg Label)

4 Tablets

71205-306-04

Medi-First ^®

Non-Aspirin

Aches, Fever ● Acetaminophen 500mg

Dolores, Fiebre ● Acetaminofeno 500mg

Aspirin-Free Pain Relief

Pull to Open

Tire Para Abrir

Compare active ingredients to:

Compare el ingrediente activo con:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Products

Marca Registrada de McNeil Consumer Products

Tamper Evident Unit Dose Packets

Empaquetado con Sellado

Evidente en Dosis Unitarias

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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

•
you are taking the blood thinning drug warfarin

Adults and Children: (12 Years and Older) (Adults and children: (12 years and older))

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains associated with • headache • common cold • muscular aches • toothache • minor arthritis pain • menstrual cramps For the reduction of fever.", "42229-5": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 tablets 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", "Purpose": "Pain reliever/fever reducer", "Directions": "• do not use more than directed", "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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor", "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.", "Other information": "• store at room temperature 59°-86°F (15°-30°C) • tamper-evident sealed packets • do not use any opened or torn packets", "Inactive ingredients": "corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide* * may contain", "Questions or comments?": "1-800-634-7680", "Children under 12 years:": "Do not give to children under 12 years of age.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Stop using and ask a doctor if": "• symptoms do not improve • new symptoms occur • pain or fever persists or gets worse • redness or swelling is present", "Active ingredient (in each tablet)": "Acetaminophen 325 mg", "Ask a doctor before use if you have": "• liver disease", "Medi-First Non-Aspirin 325 mg Label": "4 Tablets 71205-306-04 Medi-First ® Non-Aspirin Aches, Fever ● Acetaminophen 500mg Dolores, Fiebre ● Acetaminofeno 500mg Aspirin-Free Pain Relief Pull to Open Tire Para Abrir Compare active ingredients to: Compare el ingrediente activo con: Extra Strength Tylenol® Registered Trademark of McNeil Consumer Products Marca Registrada de McNeil Consumer Products Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320", "Ask a doctor or pharmacist before use if": "• you are taking the blood thinning drug warfarin", "Adults and children: (12 years and older)": "Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.637354 · Updated: 2026-03-14T23:02:32.213463