Direct Safety Aspirin Free
FDA Label NDC 61245-146

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Conney Safety Products, Llc for the product Direct Safety Aspirin Free (NDC 61245-146). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

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

    • For the reduction of fever.

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

Otc - Keep Out Of Reach Of Children

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.

Otc - Pregnancy Or Breast Feeding

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

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.

Other Information

  • store at room temperature 59°-86°F (15°-30°C)
  • 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

145 Direct Safety Aspirin Free Label

Direct Safety®

Aspirin-Free

Pain Reliever/Fever Reducer

Acetaminophen 325 mg.

Acetaminofeno 325 mg.

Industrial Pack 500

(250 Packets of 2 Tablets)

* Please review the disclaimer below.