Donatussin description, usages, side effects, indications, overdosage, supplying and lots more!

Donatussin

Laser Pharmaceuticals, LLC
Pernix Manufacturing, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Donatussin SYRUP

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4 mg

Dextromethorphan HBr 20 mg

Phenylephrine Hydrochloride 10 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

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 and sneezing, itching of the nose or throat, and itchy, water eyes
  • nasal congestion
  • reduces swelling of nasal passages

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 breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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

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.  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 6 doses in a 24 hour period.

 

Adults and children

12 years of age

and over:

1 teaspoonful (5 mL)

every 4 hours, not to

exceed 6 teaspoonfuls

in 24 hours

Children 6 to

under 12 years

of age: 

1/2 teaspoonful (2.5 mL)

every 4 hours, not to

exceed 3 teaspoonfuls

in 24 hours 

Children under

6 years of age: 

 Consult a doctor

 

Store at 59°-86°F (15°-30°C)

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

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:  16477-186-01

Donatussin
SYRUP

Improved
Formulation

Antitussive

Cough Suppressant

Nasal Decongestant


Each 5 mL (1 teaspoonful) contains:
Chlorpheniramine Maleate........................4 mg

Dextromethorphan HBr............................20 mg

Phenylephrine HCl....................................10 mg

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 broken or missing.

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

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


Rev. 11/13

Product Packaging

Product Packaging

Donatussin

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16477-186
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 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:16477-186-01 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.