Otc - Active Ingredient
Active Ingredient: Acetaminophen 160 mg (in each 5 mL)
Childrens Acetaminophen Liquid
FDA Label NDC 70005-048
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Childrens Acetaminophen Liquid (NDC 70005-048). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Pain reliever/fever reducer
Indications & Usage
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
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
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.
Otc - Do Not Use
Do not use
- with any other drug containing acetaminophen (prescription or non-prescription). if you are not sure wheather 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
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 or warfarin
When Using This Product
do not exceed recommended dose (see overdose warning)
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 5 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
Overdose Warning: 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 of symptoms.
Directions
- this product does not contain directions or complete warnings for adult use.
- Shake well before using
- mL = mililliter
- find right dose on chart below. if possible, use weight to dose; otherwise use age
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor.
Weight (lb.) Age (yrs.) Dose (mL)*
Under 24 Under 2 Ask a doctor
24-35 2-3 5mL
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
Other Information
- each 5 mL contains: sodium 7 mg
- store between 15°-30°C (59°-86°F)
- protect from freezing
- protect from light
Inactive Ingredients
citric acid, FD&C red no. 40, flavor, glycerin, PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Questions & Comments
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
Package Label.Principal Display Panel
Compare to the active ingredient in Children's Tylenol®*
Children's Acetaminophen Elixir
Cherry Flavor
For ages 2 to 11
2 FL OZ (60 mL)
This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®.
* Please review the disclaimer below.
