Label: DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61787-063-04 - Packager: Health Care Products
- 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 December 17, 2019
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- 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:
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- a cough that occurs with too much phlegm (mucus)
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- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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Directions
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- take every 4 hours
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- do not exceed 6 doses in 24 hours
adults & children 12 years and over
10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years
5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years
2.5 mL - 5 mL (½ - 1 teaspoonful)
children under 2 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
DIABETIC TUSSIN EXPECTORANT
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:61787-063-04 1 in 1 BOX 01/01/1996 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 01/01/1996 Labeler - Health Care Products (101196749) Registrant - Hi-Tech Pharmacal Co., Inc. (101196749) Establishment Name Address ID/FEI Business Operations Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(61787-063)