Direct Safety Xs Aspirin Free

Direct Safety Xs Aspirin Free
SPL v11
SPL
SPL Set ID a524c36a-38f3-4266-8f45-589e19400328
Route
ORAL
Published
Effective Date 2017-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hypromelloses Polyethylene Glycol, Unspecified Povidone 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;33 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-31 Until 2023-11-01

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

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 53414-9

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

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.

Liver Warning:

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

  • more than 8 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
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

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
175 Direct Safety Xs Aspirin Free

Direct Safety®

Extra Strength

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 500 mg.

Acetaminofeno 500 mg.

Industrial Pack 500

(250 Packets of 2 Tablets)

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have
  • liver disease
176 Direct Safety Xs Aspirin Free Label

Direct Safety®

Extra Strength Aspirin Free

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 500 mg.

Acetaminofeno 500 mg.

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

Section 50565-1 (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 53414-9 (53414-9)

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

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.

Liver Warning: (Liver warning:)

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

  • more than 8 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
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

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
175 Direct Safety Xs Aspirin Free (175 Direct Safety XS Aspirin Free)

Direct Safety®

Extra Strength

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 500 mg.

Acetaminofeno 500 mg.

Industrial Pack 500

(250 Packets of 2 Tablets)

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
176 Direct Safety Xs Aspirin Free Label (176 Direct Safety XS Aspirin Free Label)

Direct Safety®

Extra Strength Aspirin Free

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 500 mg.

Acetaminofeno 500 mg.

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


Raw Label Data

All Sections (JSON)