FDA Label for Safetynadol
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVEINGREDIENT(INEACHTABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE
- ASK A DOCTOR OR A PHARMACIST BEFORE USE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS ?
- PACKAGE LABELING:
Safetynadol Product Label
The following document was submitted to the FDA by the labeler of this product Sinew Pharma Inc.. 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.
Drug Facts
Activeingredient(Ineachtablet)
Acetaminophen 500mg
Purpose
Pain reliever/fever reducer
Uses
￭Temporarily relieves minor aches and pains due to:
￭the common cold ￭headache ￭backache ￭minor pain of arthritis ￭muscular aches ￭toothache ￭premenstrual and menstrual cramps ￭Temporarily reduces feverr
Warnings
Liver warning: This products acetaminophen. Severe liver damage may occur if you take
￭more than 4,000 mg of acetaminophen in 24 hours
￭with other drugs containing acetaminophen
￭3 or more alcohol 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 captaining acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
￭if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use
if you have liver disease
Ask A Doctor Or A Pharmacist Before Use
if you are taking blood thinning drug warfarin
Stop Use And Ask A Doctor If
￭pain gets worse or last more than 10 days ￭new symptoms occur ￭fever gets worse or lasts more than 3 days ￭redness or swelling is present
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children. Overdose Warning:
In case of over dose, get medical help or contact a Poison Control Center right away (1-800-222-1222), Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
￭do not take more than directed (see overdose warning)
| Adults and children 12 years and over | ￭take 2 tablets every 6 hours while symptoms last
￭do not take more than 6 tablets in 24 hours, unless directed by a doctor ￭do not use for more than 10 days unless directed by a doctor |
| Children under 12 years | Ask a doctor |
Other Information
Store at 20-25 °C (66-77 °F)
Inactive Ingredients
Pregelatinized Starch, polyvinylpyrrolidone K-30, Corn starch, Stearic acid, Sodium Starch Glycolate, Mannitol, Sucralose, Low Substituted Hydroxyproply Cellulose, light anhydrous silicic acid, Magnesium stearate, PEG 6000, Hydroxypropyl methylcellulose 6cps, Titanium dioxide, Sicopharm yellow 10, Sicopharm red 30
Questions Or Comments ?
x-xxx-xxx-xxxx
Package Labeling:
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