Direct Safety Aspirin Free
Direct Safety Aspirin Free
1c7369ea-46b6-407c-aa4b-048eb72ff03f
HUMAN OTC DRUG LABEL
Sep 9, 2025
Conney Safety Products, LLC
DUNS: 023316151
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)
INDICATIONS & USAGE SECTION
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.
SPL UNCLASSIFIED SECTION
Other information
- store at room temperature 59º-86ºF (15º-30ºC)
- tamper-evident sealed packets
- do not use any opened or torn packets
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 325 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
WARNINGS SECTION
Warnings
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.
DOSAGE & ADMINISTRATION SECTION
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.
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*
- may contain