Label: DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid
- NDC Code(s): 61787-063-04
- Packager: Health Care Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 5 mL)
Guaifenesin 100 mgClose
- helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- take every 4 hours
- 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
- Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
- store at room temperature 20-25°C (68-77°F).
- keep tightly closed.
- Inactive ingredients
Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.Close
- Questions or comments?
Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.
Rev #063:05 10/11Close
- Package/Label Principal Display Panel
Guaifenesin 100 mg/5 mL
Loosens & Relieves Chest Congestion
Thins & Loosens Mucus
No Sodium, Sorbitol, Fructose & Dyes
SUGAR & ALCOHOL FREE!
SAFE FOR DIABETICS
4 FL OZ (118 mL)Close
- INGREDIENTS AND APPEARANCE
DIABETIC TUSSIN EXPECTORANT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-063 Route of Administration ORAL DEA Schedule 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) HYPROMELLOSES (UNII: 3NXW29V3WO) MENTHOL (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 1 118 mL in 1 BOTTLE 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)