OTC Medication Information: Childrens Non Aspirin

CHILDRENS NON ASPIRIN — acetaminophen liquid
Kareway Product, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each 5 ml = 1 teaspoon)


Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other product containing acetaminophen

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

Keep out of reach of children.

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

do not give more than directed (see overdose warning)
  • shake well before using
  • find right dose on chart below. If possible use weight to dose; otherwise, use age.
  • if needed, repeat dose every 4 hours
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (tsp or mL)
under 24under 2ask a doctor
24-352-31 tsp or 5 mL
36-474-51 1/2 tsp or 7.5 mL
48-596-82 tsp or 10 mL
60-719-102 1/2 tsp or 12.5 mL
72-95113 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each teaspoon contains: sodium 1 mg
  • do not use if bottle wrap, or foil inner seal imprinted “SEALED for YOUR PROTECTION” is broken or missing

  • store between 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date

Inactive ingredients

propylparaben, carboxymethylcellulose sodium, citric acid, corn syrup, FD and C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sucrose, xanthan gum

Package label

Children’s Non-Aspirin

image of bottle label
(click image for full-size original)

CHILDRENS NON ASPIRIN acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0508
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
CITRIC ACID MONOHYDRATE
CORN SYRUP
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SUCRALOSE
SUCROSE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67510-0508-4 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 09/02/2011
Labeler — Kareway Product, Inc. (121840057)

Revised: 09/2011 Kareway Product, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.