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

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Chlo Tuss

Drug Facts

Active ingredients                     Purpose
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg .... Cough Suppressant
Dexbrompheniramine Maleate 1 mg..................Antihistamine
Phenylephrine Hydrochloride 5 mg ........ 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 drowsiness
• 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. These could be signs of a serious condition.
• new symptoms occur
  

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of accidental overdose, seek professional help or contact a poison control center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age:	1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children under 6 years of age:	Consult a doctor

Other information

Store at 59o-86oF (15o-30oC)

Inactive ingredients

Citric Acid, FD and C Blue #1, FD and 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

• Cough Suppressant
• Antihistamine
• Nasal 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. 09/09

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 package not intended for dispensing to the patient.

Manufactured for:

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

Rev. 09/09



Principal Display Panel and Side Panel for 15 mL Label:

NDC 12830-760-15

Chlo Tuss

• Cough Suppressant
• Antihistamine
• Nasal 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

1/2 fl oz (15 mL)

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

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

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

Rev. 10/09

Professional Sample: Not For Sale

CHLO TUSS  chlophedianol hydrochloride, dexbrompheniramine maleate, phenylephrine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 12830-760 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride 12.5 mg  in 5 mL Dexbrompheniramine Maleate (Dexbrompheniramine) Dexbrompheniramine Maleate 1 mg  in 5 mL Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 12830-760-16 473 mL In 1 BOTTLE None 2 12830-760-15 15 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/27/2009

Labeler - R.A. McNeil Company (008305220)

Revised: 11/2009R.A. McNeil Company