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Guaifenesin by Central Texas Community Health Centers

Dosage form: solution
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Central Texas Community Health Centers
NDC Code: 76413-309

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.

GUAIFENESIN

Active ingredient (in each 5 mL = 1 tsp)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic 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 is accompanied by fever, rash, or persistent headache. 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
  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

age (yr) 

dose (tsp) 

adults and children
12 years and over 

2 - 4 teaspoons
every 4 hours 

children under
12 years 

do not use

Other information
  • each tsp contains: sodium 2 mg
  • store at 15° to 30°C (59° to 86°F)
  • dosage cup provided

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

caramel color, FD&C red #40, flavor, glycerin, liquid glucose, purified water, saccharin sodium, sodium benzoate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/09 R7
8273611  0857

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

CommUnityCare Federally Qualified Health Centers

GUAIFENESIN
118ml

Date:

Name:
Dr.

TAKE AS DIRECTED.

123456

1/1/01

GUAIFENESIN 118ml NDC 76413-309-01

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

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

GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-309(NDC:0603-0857)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
FD&C RED NO. 40 
GLYCERIN 
DEXTROSE, UNSPECIFIED FORM 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
Product Characteristics
ColorORANGE (clear, reddish-orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:76413-309-01118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/1997
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-309), RELABEL(76413-309)

Revised: 04/2016
 
Central Texas Community Health Centers

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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.

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