FDA Label for Leader Childrens Pain And Fever
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Leader Childrens Pain And Fever Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 5 Ml)
Acetaminophen 160 mg
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• with other drugs containing acetaminophen• skin reddening• blisters• rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 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.• if your child has ever had an allergic reaction to this product or any of its ingredients
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 occur• redness or swelling is present
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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)• shake well before using• mL = milliliter• find right dose on chart below. If possible, use weight to dose; otherwise, use age.• remove the child protective cap and squeeze your child’s dose into the dosing cup• repeat dose every 4 hours while symptoms last• do not give more than 5 times in 24 hours
Weight (lb) | Age (yr) | Dose (mL)* |
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 5 mL |
36-47 | 4-5 years | 7.5 mL |
48-59 | 6-8 years | 10 mL |
60-71 | 9-10 years | 12.5 mL |
72-95 | 11 years | 15 mL |
*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 contains: sodium 3 mg• store at 20-25°C (68-77°F)• do not use if printed neckband is broken or missing
Inactive Ingredients
anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Children’s
Pain & Fever
Acetaminophen 160 mg per 5 mL
Oral Suspension
Pain Reliever
Fever Reducer
Bubble Gum Flavor
Alcohol-Free
Aspirin-Free
Ibuprofen-Free
Ages 2 to 11 Years
COMPARE TO CHILDREN’S TYLENOL® ORAL SUSPENSION
active ingredient
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4 FL OZ (118 mL)
* Please review the disclaimer below.