INFANTS CONCENTRATED TYLENOL
-
acetaminophen suspension/ drops
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
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- use only enclosed dropper designed for use with this product. Do not use any other dosing device.
- fill to dose level
- dispense liquid slowly into child's mouth, toward inner cheek
- 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
- replace dropper tightly to maintain child resistance
| Weight (lb) | Age (yr) | Dose (mL) |
|---|---|---|
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 1.6 mL (0.8 + 0.8 mL) |
Other Information
- store between 20-25°C (68-77°F)
- tamper evident statement
- see bottom panel of carton for lot number and expiration date
Inactive ingredients
anhydrous citric acid, butylparaben, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, xanthan gum
PRINCIPAL DISPLAY PANEL
See New Warnings Information
NDC 50580-167-01
Concentrated
TYLENOL®
Infants' Drops
Acetaminophen
Fever Reducer, Pain Reliever
INFANTS
Pediatricians'
1st Choice
Alcohol Free
Aspirin Free
Ibuprofen Free
Dye Free
NON-STAINING FORMULA
Cherry
FLAVOR
1 FL OZ (30mL) 80mg per 0.8mL
USE ONLY
Enclosed Dropper
| INFANTS CONCENTRATED TYLENOL
acetaminophen suspension/ drops |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH NOT FINAL | part343 | 12/01/2004 | 03/31/2012 |
| Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358) |
Revised: 04/2012 McNeil Consumer Healthcare Div. McNeil-PPC, Inc