Direct Safety Aspirin Free

SPL v11

SPL

SPL Set ID 1c7369ea-46b6-407c-aa4b-048eb72ff03f

Route

ORAL

Published

Effective Date 2017-03-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Hypromelloses Polyethylene Glycol, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Potato Starch, Corn Stearic Acid Titanium Dioxide Cellulose, Microcrystalline Maltodextrin Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance

Imprint: FR;2 Shape: round Color: white Size: 10 mm Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-05-31 Until 2023-06-01

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
muscular aches
minor arthritis pain
common cold
toothache
menstrual cramps

For the reduction of fever.

Section 42229-5

Drug Facts

Directions

do not use more than directed

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.

Children under 12 years: Do not give to children under 12 years of age.

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 starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* may contain

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

Direct Safety Aspirin Free Label

Direct Safety®

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 325 mg.

Acetaminofeno 325 mg.

Pull to Open

Tire Para Abrir

Industrial Pack 500

(250 Packets of 2 Tablets)

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have

liver disease

146 Direct Safety Aspirin Free Label

Direct Safety®

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 325 mg.

Acetaminofeno 325 mg.

Pull to Open

Tire Para Abrir

Industrial Pack 500

(250 Packets of 2 Tablets)

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfarin

Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with

headache
muscular aches
minor arthritis pain
common cold
toothache
menstrual cramps

For the reduction of fever.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain reliever/fever reducer

Directions

do not use more than directed

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.

Children under 12 years: Do not give to children under 12 years of age.

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 starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* may contain

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

Direct Safety Aspirin Free Label

Direct Safety®

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 325 mg.

Acetaminofeno 325 mg.

Pull to Open

Tire Para Abrir

Industrial Pack 500

(250 Packets of 2 Tablets)

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

146 Direct Safety Aspirin Free Label

Direct Safety®

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 325 mg.

Acetaminofeno 325 mg.

Pull to Open

Tire Para Abrir

Industrial Pack 500

(250 Packets of 2 Tablets)

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

you are taking the blood thinning drug warfarin

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 muscular aches minor arthritis pain common cold toothache menstrual cramps For the reduction of fever.", "42229-5": "Drug Facts", "Purpose": "Pain reliever/fever reducer", "Directions": "do not use more than directed 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. Children under 12 years: Do not give to children under 12 years of age.", "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 starch*, sodium starch glycolate*, stearic acid, titanium dioxide* * may contain", "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", "Direct Safety Aspirin Free Label": "Direct Safety® Aspirin-Free Pain Reliever/Fever Reducer Acetaminophen 325 mg. Acetaminofeno 325 mg. Pull to Open Tire Para Abrir Industrial Pack 500 (250 Packets of 2 Tablets)", "Active ingredient (in each tablet)": "Acetaminophen 325 mg", "Ask a doctor before use if you have": "liver disease", "146 Direct Safety Aspirin Free Label": "Direct Safety® Aspirin-Free Pain Reliever/Fever Reducer Acetaminophen 325 mg. Acetaminofeno 325 mg. Pull to Open Tire Para Abrir Industrial Pack 500 (250 Packets of 2 Tablets)", "Ask a doctor or pharmacist before use if": "you are taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:58.275511 · Updated: 2026-03-14T23:10:05.459246