DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid 
Health Care Products

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 Facts

Active ingredient (in each 5 mL)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

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

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

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 10/11

Package/Label Principal Display Panel

Image of Carton - 118 mL

NDC 61787-063-04

Diabetic Tussin®

Guaifenesin 100 mg/5 mL

Expectorant

Loosens & Relieves Chest Congestion

Thins & Loosens Mucus

Liquid

No Sodium, Sorbitol, Fructose & Dyes

SUGAR & ALCOHOL FREE!

SAFE FOR DIABETICS

4 FL OZ (118 mL)

DIABETIC TUSSIN EXPECTORANT 
guaifenesin liquid
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)

Revised: 9/2012
Document Id: 4b727b03-cd92-49f7-b30c-38b2610ff059
Set id: e8854680-8a9e-426e-9e1f-adcd1d45e708
Version: 2
Effective Time: 20120928
 
Health Care Products