DONATUSSIN  - chlophedianol hydrochloride, guaifenesin and phenylephrine hydrochloride syrup 
Laser Pharmaceuticals, LLC

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.

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Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg
Guaifenesin 120 mg
Phenylephrine Hydrochloride 5 mg

Purpose

Antitussive
Expectorant
Nasal Decongestant

Uses

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

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, chronic bronchitis or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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 overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed 4 doses in a 24 hour period.
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 2 to
under 6 years
of age:

1/2 teaspoonful (2.5 mL)
every 6 to 8 hours, not to
exceed 2 teaspoonfuls in
24 hours
Children under
2 years of age:
Consult a doctor


Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Berry Vanilla Flavor, Bitter Mask, Citric Acid, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.

Questions? Comments?

Call 1-864-286-8229

LASER

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC:  16477-185-01

Donatussin
SYRUP

New Improved
Formula

Antitussive

Expectorant

Nasal Decongestant


Each 5 mL (1 teaspoonful) contains:
Chlophedianol HCl...........................12.5 mg
Guaifenesin.....................................120 mg
Phenylephrine HCl...............................5 mg

Patent Pending

Berry Vanilla Flavor

LASER

16 fl oz (473 mL)


For full prescribing information, see the product foldout.

Store at 59°-86°F (15°-30°C)

Tamper-evident by foil seal under cap.  Do not use if foil
seal is brokenor missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

Dispense in a tight, light-resistant container as defined in the
USP/NF with a child-resistant closure.

The labeling for this product includes professional labeling which
is not intended for use by the general public.

WARNING:  KEEP THIS AND ALL DRUGS OUT OF REACH OF
CHILDREN.  IN CASE OF OVERDOSE, GET MEDICAL HELP OR
CONTACT A POISON CONTROL CENTER RIGHT AWAY.

LASER


Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC  29615

Patent Pending

Rev. 08/2011

Donatussin SYRUP Packaging


Donatussin SYRUP Packaging




DONATUSSIN 
chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-185
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin120 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 
Sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (Berry Vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:16477-185-01473 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/28/2011

Labeler - Laser Pharmaceuticals, LLC (614417132)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 09/2011 Laser Pharmaceuticals, LLC