Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Childrens Acetaminophen (NDC 70005-049). 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, liver warning:, sore throat warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Pain reliever/Fever reducer
temporarily:
the common cold
flu
headache
sore throat
toothache
This product contains acetaminophen. Severe liver damage may occur if your child takes
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.
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
When using this product do not exceed recommended dose (see overdose warning)
These could be signs of a serious condition.
Keep out of reach of children.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Weight (lb.) Age(yrs.) 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
* always check with your doctor before administering medicine to your infant/child
citric acid, FD&C red # 40, FD&C blue # 1, flavor, glycerin. PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
*Compare to the active ingredient in Children's Tylenol® Elixir
Children's Acetaminophen Elixir
Grape Flavor
For ages 2 to 11
2 FL OZ (60 mL)
* Please review the disclaimer below.