Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Childrens Pain And Fever (NDC 76162-079). 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.
liver disease.
taking the blood thinning drug warfarin.
These could be signs of a serious condition.
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, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
1-888-423-0139
TopCare®
health
COMPARE TO CHILDREN'S TYLENOL®
ORAL SUSPENSION ACTIVE INGREDIENT**
NDC 76162-079-36
children's
Pain &
Fever
ACETAMINOPHEN,
160 mg per 5 mL
ORAL SUSPENSION
PAIN RELIEVER • FEVER REDUCER
• Aspirin Free
•Ibuprofen Free
•Alcohol Free
STRAWBERRY
FLAVOR
Ages 2
to
11 years
4 FL OZ (118 mL)
**This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Children's Tylenol® Oral Suspension.
50844 ORG092207936
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0623
QUESTIONS? 1-888-423-0139
[email protected]
www.topcarebrand.com
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Scan here for more
information or
call 1-888-423-0139
DIRECTIONS:
STEP 1.
Shake well
before using
STEP 2.
Remove child
protective
cap
STEP 3.
Pour your
child’s dose
into the
dosing cup
Please see dosing chart or ask
a doctor for your child’s correct dose
* Please review the disclaimer below.