FDA Label for Fridababy Children Pain And Fever Acetaminophen 160mg Per 5ml Vial 10ct
View Indications, Usage & Precautions
Fridababy Children Pain And Fever Acetaminophen 160mg Per 5ml Vial 10ct Product Label
The following document was submitted to the FDA by the labeler of this product Fridababy 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.
Active Ingredient (In Each 5Ml)
Acetaminophen, 160mg
Purpose
Pain reliever/fever reducer
Uses
temporarily:
■ reduces fever
■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount for this product
■ with other drugs containing acetaminophen.
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
Sore throat warning: if sore throat is severe, persistent for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. Consult a doctor promptly.
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.
Ask A Doctor Before Use If Your Child
has liver disease
Ask A Doctor Or Pharmacist Before Use If Your
child is taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
■ pain gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present. These could be signs of a serious condition.
Overdosage
In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.
Directions
■ this product does not contain directions or complete warnings for adult use
■ do not give more than directed (see overdose warning)
■ use the chart below to confirm dose. If possible, use weight to dose, otherwise, use age.
■ give the recommended number of vials below. To open, follow the instructions under How to Use.
■ if needed, repeat dose every 4 hours while symptoms last.
■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed by a doctor
Weight (lbs) | Age (Years) | Dose |
under 24 lbs. | under 2 years | Ask a doctor |
24-35 lbs. | 2 - 3 years | 1 Single Use Vial (5 mL) |
36-47 lbs. | 4-5 years | Ask a doctor |
48-71 lbs. | 6-10 Years | 2 Single Use Vial (10 mL) |
72-95 lbs | 11 years | 3 Single Use Vial (15 mL) |
Other Information
■ Each Single Use Vial contains 8mg of sodium
■ Store at 68-77°F (20-25°C)
■ Tamper Evident: do not use if the pouch is damaged, open or broken. Do not use if any vial is open or broken.
Inactive Ingredient
citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.
Questions Or Comments?
1-833-WTF-FRIDA (1-833-983-3743)
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