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

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

Active Ingredient

Acetaminophen 500 mg

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.

Purpose

Pain reliever/fever reducer

Directions
  • do not use more than directed
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

Description

Drug Facts

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.

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
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)

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

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 500 mg

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.

Purpose

Pain reliever/fever reducer

Directions
  • do not use more than directed
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

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.

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
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)

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)