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Donatussin

Laser Pharmaceuticals, LLC
Great Southern Laboratories

Donatussin SYRUP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)




Purpose




Donatussin Uses


  • 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
  • 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, 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,

Keep out of reach of children.


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


Donatussin Other information


Inactive ingredients


Questions? Comments?








Product Packaging





NDC:  16477-185-01

Donatussin
SYRUP

New Improved
Formula

Antitussive

Expectorant

Nasal Decongestant



Chlophedianol HCl...........................12.5 mg
Guaifenesin.....................................120 mg
Phenylephrine HCl...............................5 mg

Patent Pending



LASER

16 fl oz (473 mL)


For full prescribing information, see the product foldout.






THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.







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



Laser Pharmaceuticals, LLC






Donatussin

Donatussin


Donatussin

Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16477-185
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlophedianol Hydrochloride Chlophedianol 12.5 mg
Guaifenesin GUAIFENESIN 120 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
Citric acid
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16477-185-01 473 in 1 BOTTLE
2 NDC:16477-185-15 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-09-28


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