Diabetic Tussin Mucus Relief

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg
Labeler: Health Care Products
NDC Code: 61787-445

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 caplet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make coughs more productive

Warnings

Ask a doctor before use if you have
  • persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if
  • symptoms are accompanied by fever, rash, or persistent headache
  • cough persists for more than 1 week or tends to recur

    A persistent cough may be a sign of a serious condition.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions
  • take every 4 to 6 hours
  • do not exceed more than 6 doses in 24 hours
  • Take with a full glass of water
adults & children 12 years & over1 caplet
children 6 years to under 12 years1/2 caplet
children under 6 yearsask a doctor

Other information
  • Store at room temperature 15° - 30°C (59° - 86°F).

Inactive ingredients

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid.

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. 445:02 7/09

Package/Label Principal Display Panel

NDC 61787-445-50

Diabetic Tussin®

EX400 Guaifenesin 400 mg

EXPECTORANT

Mucus Relief

RELIEVES CHEST CONGESTION

Thins & Loosens Mucus

IMMEDIATE RELEASE

50 Easy to swallow Caplets

 

Sorbitol Free & Fructose Free!

SUGAR, SODIUM & DYE FREE!

SAFE FOR DIABETICS

DIABETIC TUSSIN MUCUS RELIEF 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-445
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeBULLETSize17mm
FlavorImprint CodeNL;275
Contains    
Packaging
#Item CodePackage Description
1NDC:61787-445-501 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/200102/28/2015
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co.004172052REPACK(61787-445)
Establishment
NameAddressID/FEIOperations
Pharbest Pharmaceuticals, Inc.557054835MANUFACTURE(61787-445)

Revised: 06/2011
 
Health Care Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)