Label: CHILDRENS NON ASPIRIN- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0508-4 - Packager: Kareway Product, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 2, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 ml = 1 teaspoon)
- Purpose
- Uses
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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.
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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
Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.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
- Other information
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
CHILDRENS NON ASPIRIN
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0508 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0508-4 120 mL in 1 BOTTLE 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)