FDA Label for Childrens Pain Relief
View Indications, Usage & Precautions
Childrens Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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(S)
Acetaminophen 160 mg
(in each 5 mL = 1 teaspoonful)
Purpose
Pain reliever/fever reducer
Use(S)
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 ■ 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, persists for more than 2 days, is accompanied or followed by ever, 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.
■ If your child is allergic to acetaminophen or any other of the inactive ingredients in this product.
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.
When Using This Product
do not exceed recommended dose (see overdose warning)
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 ■ redness or swelling is present. These could be signs of a serious condition.
Keep Out Of Reach Of Children
Overdose warning: Taking more than the recommended dose (overdose) may
cause liver damage. In case of overdose, get medical help or contact a Poison
Control Center (1-800-222-1222) right away. Quick medical attention is critical
for adults as well as for children even if you do not notice any signs or
symptoms.
Directions
■ this product does not contain directions or complete warnings for adult use.■ shake well before using
■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
■ 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 (lb) | Age (yr) | Dose (mL)* |
|---|---|---|
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 5 mL(1 tsp) |
36-47 | 4-5 years | 7.5 mL(1 1/2 tsp) |
48-59 | 6-8 years | 10 mL(2 tsp) |
60-71 | 9-10 years | 12.5 mL(2 1/2 tsp) |
72-95 | 11 years | 15 mL(3 tsp) |
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this
product. Do not use any other dosing device.
Other Information
■ each 5 mL (1 tsp) contains; sodium 3 mg ■ store between 20-25°C (68-77°F) ■ do not refrigerate ■ Keep carton for full directions for use.
Inactive Ingredients
anhydrous citric acid, butylparaben, FD&C red
#40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and
carboxymethylcellulose sodium, propylene glycol, purified water, sodium
benzoate, sorbitol solution, sucralose, xanthan gum
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST
Principal Display Panel
Pain Relief
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