FDA Label for Direct Safety Extra Strength Aspirin Free
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- LIVER WARNING:
- ALLERGY ALERT:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- STOP USING AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- 175 DIRECT SAFETY XS ASPIRIN FREE
- 176 DIRECT SAFETY XS ASPIRIN FREE LABEL
Direct Safety Extra Strength Aspirin Free Product Label
The following document was submitted to the FDA by the labeler of this product Conney Safety Products, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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.
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.
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
- headache
- muscular aches
- minor arthritis pain
- common cold
- toothache
- menstrual cramps
For the reduction of fever.
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 - 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
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
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)
* Please review the disclaimer below.