Label: CHEST CONGESTION- guaifenesin solution
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Contains inactivated NDC Code(s)
NDC Code(s): 45014-163-04 - 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 February 6, 2013
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 = 1 teaspoon)
- Purpose
- Uses
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WARNINGS
Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or persistant or chronic cough such as occurs with asthma.
Directions
- may be given every 4 hours
- do not use more than 6 times in 24 hours
- use only enclosed dosing cup to dose this product. Do not use any other dosing device.
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.
Age (yr) Dose (TSP) TSP = teaspoon under 4 yrs. ask a doctor 4 to under 6 ½ TSP to 1 TSP 6 to under 12 1 TSP to 2 TSP or as directed by a doctor - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
CHEST CONGESTION
guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-163 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 Citric Acid Monohydrate (UNII: 2968PHW8QP) Corn Syrup (UNII: 9G5L16BK6N) FD&C Blue No. 1 (UNII: H3R47K3TBD) D&C Red No. 33 (UNII: 9DBA0SBB0L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Sodium Benzoate (UNII: OJ245FE5EU) Saccharin Sodium (UNII: SB8ZUX40TY) Sucralose (UNII: 96K6UQ3ZD4) Xanthan Gum (UNII: TTV12P4NEE) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-163-04 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/01/2013 Labeler - Accudial Pharmaceutical, Inc. (831999201)