First Aid Only Extra-strength Non-aspirin

SPL v2

SPL

SPL Set ID 6891d57a-10a6-53de-e053-2a91aa0ac7c2

Route

ORAL

Published

Effective Date 2018-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Polyethylene Glycol Hypromelloses Povidone Sodium Starch Glycolate Type A Potato Starch, Corn 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

temporarily reduces 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? 1-800-835-2263

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

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.

First Aid Only Extra Strength Non Aspirin Label

First Aid Only Extra-Strength Non-Aspirin Label

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

temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 53413-1 (53413-1)

Questions? 1-800-835-2263

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

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.

First Aid Only Extra Strength Non Aspirin Label (First Aid Only Extra-Strength Non-Aspirin Label)

First Aid Only Extra-Strength Non-Aspirin Label

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "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": "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 temporarily reduces 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? 1-800-835-2263", "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", "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.", "First Aid Only Extra-Strength Non-Aspirin Label": "First Aid Only Extra-Strength Non-Aspirin Label"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:32.402901 · Updated: 2026-03-14T23:05:21.514130