Label: CHEST CONGESTION- guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 45014-150-04 - Packager: Accudial Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 15, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL tsp)
- Purpose
- Uses
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Warnings
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
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Directions
- do not take more than 6 doses in any 24-hour period
- to find right dose, use rotating bottle label to dose by weight; otherwise, use chart at right to dose by age
- specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product.
Do not use any other device
Age Dose children 6 years to under 12 years 5 mL to 10 mL or 1-2 teaspoonfuls every 4 hours childen 4 years to under 6 years 2.5 mL to 5 mL or 1/2-1 teaspoonful every 4 hours children under 4 years do not use - Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 118 mL Carton
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INGREDIENTS AND APPEARANCE
CHEST CONGESTION
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-150 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength Caramel (UNII: T9D99G2B1R) Citric Acid Monohydrate (UNII: 2968PHW8QP) Corn Syrup (UNII: 9G5L16BK6N) FD&C RED NO. 40 (UNII: WZB9127XOA) Glycerin (UNII: PDC6A3C0OX) Menthol (UNII: L7T10EIP3A) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Benzoate (UNII: OJ245FE5EU) Saccharin Sodium (UNII: SB8ZUX40TY) Product Characteristics Color RED (Reddish-Pink) , PINK Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-150-04 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/26/2009 Labeler - Accudial Pharmaceutical, Inc. (831999201)
