Label: DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-335-01 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 61787-063
- 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 August 15, 2017
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)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have:
- a cough that occurs with too much phlegm (mucus)
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label
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INGREDIENTS AND APPEARANCE
DIABETIC TUSSIN EXPECTORANT
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-335(NDC:61787-063) 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color Score Shape Size Flavor CHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-335-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/1996 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-335) , RELABEL(76413-335)