DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid 
Central Texas Community Health Centers

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

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

City of Austin Dept of Health

GUAIFENESIN
118ml

Date:

Name:
Dr.

TAKE AS DIRECTED.

1/1/01

123456

GUAIFENESIN 118ml NDC 76413-335-01

Batch: 123456
Lot: 123456
Exp: 1/1/01

AKORN

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label
DIABETIC TUSSIN EXPECTORANT 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-335(NDC:61787-063)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76413-335-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1996
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK(76413-335) , RELABEL(76413-335)

Revised: 8/2017
Document Id: 494c896e-9a61-4e4a-b301-c81e97ba7bd7
Set id: 18f4c0c4-4448-470c-bd82-8d6cd3f8cd71
Version: 1
Effective Time: 20170815
 
Central Texas Community Health Centers