Acetaminophen 500 Mg

SPL v4

SPL

SPL Set ID c466a07f-2339-4cf5-8377-e0f109649c52

Route

ORAL

Published

Effective Date 2024-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

For the temporary relief of minor aches and pains associated with

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

For the reduction of fever.

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 53413-1

Questions or comments? 1-800-634-7680

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 59º-86ºF (15º-30ºC)
•
tamper-evident sealed packets
•
do not use any opened or torn packets

Inactive Ingredients

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

* May contain

Xs Apap 500 Mg Label

Extra Strength

APAP

Non-Aspirin Tablets

This Package is For Households Without Young Children

Pull to Open

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

8 Tablets

(2 x 4)

Tamper Evident Unit Dose Packets

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Children Under 12 Years:

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may cause liver damage.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Stop Using and Ask A Doctor If

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

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have

•
liver disease

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 8 tablets in 24 hours.

Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with

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

For the reduction of fever.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

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 59º-86ºF (15º-30ºC)
•
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 corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* May contain

Xs Apap 500 Mg Label (XS APAP 500 mg Label)

Extra Strength

APAP

Non-Aspirin Tablets

This Package is For Households Without Young Children

Pull to Open

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

8 Tablets

(2 x 4)

Tamper Evident Unit Dose Packets

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may cause liver damage.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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

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

Acetaminophen 500 mg

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

•
liver disease

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 8 tablets in 24 hours.

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE, UNSPECIFIED", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains associated with • headache • toothache • minor arthritis pain • muscular aches • common cold • menstrual cramps For the reduction of fever.", "42229-5": "Drug Facts", "50565-1": "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.", "53413-1": "Questions or comments? 1-800-634-7680", "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 59º-86ºF (15º-30ºC) • tamper-evident sealed packets • do not use any opened or torn packets", "Inactive ingredients": "corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide* * May contain", "XS APAP 500 mg Label": "Extra Strength APAP Non-Aspirin Tablets This Package is For Households Without Young Children Pull to Open Pain Reliever/Fever Reducer ● Acetaminophen 500mg 8 Tablets (2 x 4) Tamper Evident Unit Dose Packets Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320", "Children under 12 years:": "Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Stop using and ask a doctor if": "• symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present", "Active ingredient (in each tablet)": "Acetaminophen 500 mg", "Ask a doctor before use if you have": "• liver disease", "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 8 tablets in 24 hours."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:48.433186 · Updated: 2026-03-14T23:02:33.495898