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Chlo Tuss

R.A. McNeil Company

Chlo Tuss


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Chlo Tuss 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

Chlo Tuss Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerine, 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 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. 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


Chlo Tuss




Chlo Tuss

Chlophedianol Hydrochloride, Dexbrompheniramine Maleate, Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:12830-760
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlophedianol Hydrochloride Chlophedianol 12.5 mg
Dexbrompheniramine Maleate DEXBROMPHENIRAMINE 1 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12830-760-16 473 in 1 BOTTLE
2 NDC:12830-760-15 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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