CHILDRENS TYLENOL- acetaminophen suspension
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Active ingredient (in each 5 mL = 1 teaspoonful)
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
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 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
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.
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.
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; tsp = teaspoonful
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and pour 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 or tsp) * |
|
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 (1½ tsp) |
48-59 | 6-8 years | 10 mL (2 tsp) |
60-71 | 9-10 years | 12.5 mL (2½ tsp) |
72-95 | 11 years | 15 mL (3 tsp) |
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 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, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions or comments?
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
NDC 50580-164-04
See New Warning
Children's
TYLENOL®
Acetaminophen Oral Suspension
Pain Reliever-Fever Reducer
Pain+Fever
Ages 2-11
For In-Patient Use Only
Hospital/Government
Not For Retail Sale
Ibuprofen Free
Alcohol Free
Aspirin Free
4 fl oz (120 ml)
(160 mg per 5 ml)
Grape
Flavor