Label: GUAAP- guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-051-21 - Packager: A P J Laboratories Limited
- 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 28, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- purpose
- keep out of reach of children
- uses
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warning
Ask a doctor before use if you have
•cough that occurs with too much phlegm (mucus)
•cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- direction
- inactive ingredient
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUAAP
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-051 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 MENTHOL (UNII: L7T10EIP3A) 10 ug in 5 mL SUCROSE (UNII: C151H8M554) 200 mg in 5 mL SORBITOL (UNII: 506T60A25R) 50 mg in 5 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg in 5 mL BRONOPOL (UNII: 6PU1E16C9W) 0.5 mg in 5 mL EDETIC ACID (UNII: 9G34HU7RV0) 0.5 mg in 5 mL ASPARTAME (UNII: Z0H242BBR1) 1 mg in 5 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.5 mg in 5 mL Product Characteristics Color yellow Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-051-21 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-051)
