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.

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Drug Facts

Active ingredient (in each 5 ml = 1 teaspoon)


Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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.

Enter section text here

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)
Weight (lb)
Age (yr)
Dose (tsp or mL)
under 24
under 2
ask a doctor
24-35
2-3
1 tsp or 5 mL
36-47
4-5
1 1/2 tsp or 7.5 mL
48-59
6-8
2 tsp or 10 mL
60-71
9-10
2 1/2 tsp or 12.5 mL
72-95
11
3 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

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-Aspirinimage of bottle label

CHILDRENS NON ASPIRIN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0508
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0508-4120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/02/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 9/2011
Document Id: b9c37609-fab1-48bc-b9a2-64c67e9760d4
Set id: c3525848-f759-4843-93ec-606c4afcd718
Version: 1
Effective Time: 20110902
 
Kareway Product, Inc.