Label: DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid
- NDC Code(s): 61787-514-04
- Packager: Akorn Consumer Health
- 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.
Updated October 5, 2020
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- Active ingredient (in each 10 mL)
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
Stop use and ask a doctor if:
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
These could be signs of a serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
DIABETIC TUSSIN EXPECTORANT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-514 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) CHERRY (UNII: BUC5I9595W) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) VANILLA (UNII: Q74T35078H) 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:61787-514-04 1 in 1 BOX 02/01/2020 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/01/2020 Labeler - Akorn Consumer Health (117696761) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Hi-Tech Pharmacal Co., Inc. 117696873 MANUFACTURE(61787-514)