Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Childrens Pain And Fever (NDC 51316-099). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
liver disease.
taking the blood thinning drug warfarin.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Weight (lb) | Age (yr) | Dose (mL)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 5 mL |
| 36-47 | 4-5 | 7.5 mL |
| 48-59 | 6-8 | 10 mL |
| 60-71 | 9-10 | 12.5 mL |
| 72-95 | 11 | 15 mL |
*or as directed by a doctor
anhydrous citric acid, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
1-800-426-9391
NDC 51316-099-36
♥CVS™
Ages
2-11
years
Bubble Gum Flavor
Children's
PAIN & FEVER
Acetaminophen
160 mg / 5 mL
Oral Suspension
Pain Reliever, Fever Reducer
Compare to Children's Tylenol®
Oral Suspension active ingredient†
Free of:
Aspirin, Ibuprofen & Parabens
No Added Alcohol
DYE
FREE
4 FL OZ (118 mL)
dosing cup
included
DIRECTIONS:
STEP 1.
Shake well
before using
STEP 2.
Remove child
protective cap
STEP 3.
Pour your
child’s dose
into the
dosing cup
IMPORTANT:
Please see dosing chart or ask a doctor
for your child’s correct dose
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
†This product is not manufactured or distributed
by Kenvue Inc., owner of the registered
trademark Children’s Tylenol® Oral Suspension.
50844 ORG012609936
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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