FDA Label for Childrens Tylenol
View Indications, Usage & Precautions
- CHILDRENS TYLENOL
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- LIVER WARNING
- OTHER
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PRINCIPAL DISPLAY PANEL
Childrens Tylenol Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. 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.
Childrens Tylenol
Drug Facts
Drug Facts
Active Ingredient (In Each Tablet)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
- temporarily reduces fever
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
temporarily:
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
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
This product contains acetaminophen. Severe liver damage may occur if your child takes
Other
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- 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 fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 is allergic to acetaminophen or any of the inactive ingredients in this product
- 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 of the inactive ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
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
- 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.
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 for adults as well as for children even if you do not notice any signs or symptoms.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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.
- do not give more than directed (see overdose warning)
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew tablets completely before swallowing; do not swallow tablets whole
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- 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 (tablets) or as directed by a doctor |
---|---|---|
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 1 tablet |
36-47 | 4-5 years | 1½ tablets |
48-59 | 6-8 years | 2 tablets |
60-71 | 9-10 years | 2½ tablets |
72-95 | 11 years | 3 tablets |
Weight (lb) | Age (yr) | Dose (mL) or as directed by a doctor |
---|---|---|
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 |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
- store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
- do not use if neck band or foil inner seal imprinted with "TYLENOL" is broken or missing
- each 5 mL contains: sodium 2 mg
- store between 20-25°C (68-77°F)
- do not use if carton tape imprinted "TYLENOL" or bottle wrap imprinted "TYLENOL" is broken or missing
Inactive Ingredients
anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose
anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Principal Display Panel
NDC 50580-460-01
Children's
TYLENOL®
Acetaminophen (160 mg per 5 mL)
Oral Suspension
Pain Reliever-Fever Reducer
Pain+Fever
Ages 2-11 Years
Ibuprofen Free
Alcohol Free
Aspirin Free
4 fl oz (120 mL)
160 mg per 5 mL
Grape
Flavor
BE READY
AT HOME
OR
ON-THE-GO
Use products only as directed.
NDC 50580-460-01
New Strength & Directions
Children's
TYLENOL®
Acetaminophen
Pain Reliever
Fever Reducer
Pain+Fever
Ages 2-11
Chewables
Ibuprofen Free, Aspirin Free
Now
160 mg
Per Tablet
24
Chewable
Tablets
Actual Size
160 mg each
Grape Flavor
* Please review the disclaimer below.