FDA Label for Only For Fever
View Indications, Usage & Precautions
Only For Fever Product Label
The following document was submitted to the FDA by the labeler of this product O4 Global Trading Usa, 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.
Drug Facts
Active Ingredient (In Each Caplet)
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 • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever
Warnings:
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 3,000mg of acetaminophen 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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product
• 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 a pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
If pregnant or breast-feeding,
ask a health professional before use.
Keep Out Of Reach Of Children
Overdose Warning: 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:
- take with a full glass of water
- do not take more than directed (See Overdose Warning)
adults and children 12 years of age & over | • take 2 caplets every 6 hours while symptoms persist. • do not take more than 6 caplets 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 of age | ask a doctor |
Other Information:
• Store at room temperature between 20-25°C (68-77°F).
Inactive Ingredients:
colloidal silicon dioxide, gelatin, glycerin, hydroxypropyl methyl cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycolate.
Questions Or Comments ?
1-833-665-9444.
Packaging
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