Donatussin
Laser Pharmaceuticals, LLC
Pernix Manufacturing, LLC
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.
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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
DonatussinChlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride SYRUP
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