Childrens Acetaminophen
FDA Label NDC 70005-041

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 Distributors Inc. for the product Childrens Acetaminophen (NDC 70005-041). 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, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Acetaminophen.............................Pain reliever/fever reducer

Uses

  • temporarily reduces fever
  • temporarily relieves minor aches and pains 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
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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this 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 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 more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.

Keep Out Of The Reach Of Children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or
symptoms.

Directions

• this product does not contain directions or complete warnings for adult use.
• shake well before using

• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• 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                             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

Other Information

  • each teaspoon (mL) contains: Sodium 3 mg
  • store between 150-300C (590-860F)
  • Protect from freezing
  • Protect from light

Inactive Ingredients

butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red #40, flavor, glycerin, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

Compare to the active ingredient in Children's Tylenol®*
Children's Pain Relief
Suspension Liquid
Cherry Flavor
For ages 2 to 11
2 FL OZ (60 mL)

* Please review the disclaimer below.