FDA Label for Childrens Pain And Fever
View Indications, Usage & Precautions
Childrens Pain And Fever Product Label
The following document was submitted to the FDA by the labeler of this product Calmco 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.
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
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 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms (1-800-222-1222)
Directions
• do not give more than directed (see overdose warning)
• use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age
• give the recommended number of vials below.
• empty each Single-Use Vial required of all liquid when dosing
• 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
• this product does not contain directions or complete warnings for adult use.
• How to Open & Use:
1. Flick the tip before opening so liquid descends.
2. Twist the tip until open and discard immediately.
3. Place open end into child’s mouth and Squeeze to dispense all liquid and discard.
Dosing Chart
Weight (lbs) | Age (Years) | Dose (mL) |
under 24 lbs | under 2 years | Talk to a doctor |
24 -35 lbs | 2 - 3 years | 1 Single-Use Vial (5 mL) every 4 hours while symptoms last. Do not exceed 5 Single-Use Vials in 24 hours |
Other Information
- each Single-Use vial contains 8mg of sodium
- store at 20-25°C (68-77°F)
- tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
Inactive Ingredients
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?
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