INFANTS TYLENOL- acetaminophen suspension
McNeil Consumer Healthcare Div. McNeil-PPC, Inc
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.
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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
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
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.
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 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
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- push air out of syringe. Firmly push syringe into bottle opening
- turn bottle upside down and pull syringe to the correct dose
- dispense liquid slowly into child's mouth, toward inner cheek
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- replace cap tightly to maintain child resistance
| Weight (lb) | Age (yr) | Dose (mL) * |
|---|---|---|
|
||
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.
Other information
- store between 20-25°C (68-77°F)
- do not use if carton tape imprinted "SAFETY SEAL®" or bottle wrap imprinted "SAFETY SEAL®" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing
- see bottom panel for lot number and expiration date
Inactive ingredients
anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
PRINCIPAL DISPLAY PANEL
See New Dosage & Directions
NDC 50580-191-01
Infants'
TYLENOL®
For Children
Acetaminophen Oral Suspension
Pain Reliever-Fever Reducer
INFANTS
NEW!
Dosage
& Directions
Ibuprofen Free
Alcohol Free
Aspirin Free
Use Only Enclosed Syringe
Grape
FLAVOR
SimpleMeasure™
See side panel for more information
1 fl oz (30 ml)
160 mg per 5 ml
| INFANTS TYLENOL
acetaminophen suspension |
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| Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358) |