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 pain 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 has ever had an allergic reaction to this product or any of its ingredients
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 even if you do not notice any sign or symptoms.
Directions
• this product does not contain directions or complete
warnings for adult use
• do not take 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?
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
Principal Display Panel
Compare to the active ingredient in Children’s Tylenol® Oral Suspension**
Suspension Liquid
NDC 51316-975-08
Children’s Pain & Fever
ACETAMINOPHEN
160 mg / 5 mL
Pain reliever; Fever reducer
Ages 2 to 11 years
Free of:
• Added Alcohol
• Aspirin
• Ibuprofen
Grape Flavor
Use ONLY Enclosed Dosing Cup
Actual Bottle Size on Side Panel
8 FL OZ (237 mL)
* Please review the disclaimer below.