DONATUSSIN- chlophedianol hydrochloride, guaifenesin, 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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Donatussin SYRUP
Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Guaifenesin 120 mg
Phenylephrine Hydrochloride 5 mg
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
- 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.
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
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.
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
|
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 broken or 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
chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride syrup |
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| Labeler - Laser Pharmaceuticals, LLC (614417132) |