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.

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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 years5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years2.5 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61787-063
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
HYPROMELLOSES 
MENTHOL 
METHYLPARABEN 
POTASSIUM SORBATE 
WATER 
ANHYDROUS CITRIC ACID 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-063-041 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1996
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(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