Direct Safety XS Aspirin Free
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 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
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
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
- do not use more than directed
SPL UNCLASSIFIED SECTION
Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.
SPL UNCLASSIFIED SECTION
Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
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
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)
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)