Chlo Tuss EX

Dosage form: liquid
Ingredients: Chlophedianol Hydrochloride 12.5mg in 5mL, Guaifenesin 100mg in 5mL
Labeler: R. A. McNeil Company
NDC Code: 12830-767

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.

Chlo Tuss EX

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg
Guaifenesin 100 mg

PurposeCough Suppressant
Expectorant

Usestemporarily relieves these symptoms due to the common cold:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Ask a doctor before use if you have
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if
  • a cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

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 exceed recommended dosage.
Adults and children
12 years of age
and over:

2 teaspoonfuls (10 mL)
every 6 hours, not to
exceed 8 teaspoonfuls
in 24 hours
Children 6 to under
12 years of age:


1 teaspoonful (5 mL)
every 6 hours, not to
exceed 4 teaspoonfuls
in 24 hours
Children under 6
years of age:
Consult a doctor


Other informationStore at 59°-86°F (15°-30°C).

Inactive ingredientsBerry Vanilla Flavor, Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose

Questions? Comments?Call 1-423-493-9170

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 12830-0767-16

Chlo Tuss EX

Cough Suppressant • Expectorant

Alchol Free • Gluten Free
Sugar Free • Dye Free

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol HCl.........................12.5 mg
Guaifenesin...................................100 mg

Patent Pending

Berry Vanilla Flavor

ONE PINT (473 mL)

Mfg. for R.A. McNeil Company
Chattanooga, TN  37406-3738

Rev. 08/11

Tamper evident by foil seal under cap.  Do not
use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO
THE CONSUMER.


Dispense in a tight, light-resistant container
with a child-resistant cap.

Patent Pending

Manufactured for:
R.A. McNeil Company
1150 Latta Street
Chattanooga, TN  37406-3738

Rev. 08/11






CHLO TUSS  EX
chlophedianol hydrochloride, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12830-767
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol ) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (Berry Vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:12830-767-16473 mL in 1 BOTTLE
2NDC:12830-767-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/2011
Labeler - R. A. McNeil Company (008305220)

Revised: 11/2011
 
R. A. McNeil Company

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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