FDA Label for Childrens Pain And Fever
View Indications, Usage & Precautions
Childrens Pain And Fever Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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
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
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
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.
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: 2 mg
- Store at 20° to 25°C (68° to 77°F)
- do not use if printed neckband is broken or missing
Inactive Ingredients
acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
Questions Or Comments?
Call 1-800-845-8210.
** This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children's Tylenol® Oral Suspension.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
v-38612
Principal Display Panel
NDC 51316-781-04
Ages 2-11 Years
Children's
acetaminophen
(160 mg per 5 mL)
Oral Suspension
Pain Reliever+Fever Reducer
Made in the USA
Strawberry Flavor
Ibuprofen Free • Alcohol Free •Aspirin Free
4 fl oz (118 mL)
* Please review the disclaimer below.