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Direct Safety Aspirin Free


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient (in each tablet)

Acetaminophen 325 mg


Purpose

Pain reliever/fever reducer


Uses

For the temporary relief of minor aches and pains associated with

For the reduction of fever.

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

Warnings


SPL UNCLASSIFIED SECTION

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

  • more than 12 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

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.


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

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

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

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.


Directions

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 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


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)


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)