CHLO TUSS - chlophedianol hydrochloride, dexbrompheniramine maleate and phenylephrine hydrochloride liquid 
R.A. McNeil Company

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 ingredients             
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Dexbrompheniramine Maleate 1 mg
Phenylephrine Hydrochloride 5 mg

Purpose

Cough Suppressant
Antihistamine
Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages


Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion 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 accidental 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 to 8 hours, not
to exceed 8 teaspoonfuls
in 24 hours


Children 6 to
under 12 years
of age:

1 teaspoonful (5 mL)
every 6 to 8 hours, not
to exceed 4 teaspoonfuls
in 24 hours
Children under
6 years of age:
Consult a doctor

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170
(8 a.m. to 5 p.m.)

PRODUCT PACKAGING

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473mL Label:

NDC 12830-760-16

Chlo Tuss

Patent Pending

Cough SuppressantAntihistamineNasal Decongestant
Grape Flavor

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol Hydrochloride........... 12.5 mg
Dexbrompheniramine Maleate............ 1 mg
Phenylephrine Hydrochloride.............. 5 mg

Alcohol Free / Gluten Free
Sugar Free

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.

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

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.
Manufactured for:
R.A. McNeil Company
1150 Latta Street
Chattanooga, TN 37406-3738

Patent Pending

Rev. 08/11

Chlo Tuss Packaging


Chlo Tuss Packaging
CHLO TUSS 
chlophedianol hydrochloride, dexbrompheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12830-760
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Dexbrompheniramine Maleate (Dexbrompheniramine) Dexbrompheniramine Maleate1 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:12830-760-16473 mL in 1 BOTTLE
2NDC:12830-760-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/27/2009
Labeler - R.A. McNeil Company (008305220)

Revised: 09/2011
Document Id: bc4fd377-cde1-4c34-8817-1168989d6681
Set id: 77120e18-82d8-4b18-be55-617517a34c47
Version: 2
Effective Time: 20110915
 
R.A. McNeil Company