DESPEC DM
-
dextromethorphan hydrobromide,
guaifenesin and
phenylephrine hydrochloride syrup
International Ethical Laboratories, Inc.
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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Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide 15 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
Do not exceed recommended dosage.
Adults and Children 12 years of age and over: | 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 4 doses in 24 hours. |
Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in 24 hours. |
Children under 6 years of age: | Consult a doctor. |
citric acid, glycerin, grape flavor, maltitol, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.
Call 1-787-765-3510.
Distributed for:
International Ethical Laboratories, Inc.
San Juan, Puerto Rico 00918-2627
The packaging below represents the labeling currently used.
Principal Display Panel and Side Panel for 120 mL Label:
NDC 11584-1045-4
DESPEC DM SYRUP
Grape Flavor
Antitussive · Expectorant · Decongestant
Sugar Free · Dye Free · Alcohol Free
Each teaspoonful (5 mL) contains:
Dextromethorphan HBr........... 15 mg
Guaifenesin..........................100 mg
Phenylephrine HCl.................. 5 mg
CONTENTS: 120 mL (4 oz)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container with a child-resistant cap.
Manufactured by:
Great Southern
Laboratories,
Houston, TX 77099
Distributed for:
International Ethical
Laboratories, Inc.
San Juan, Puerto Rico 00918-2627
Iss. 01/12
DESPEC
DM
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part341 | 11/01/2002 |
Labeler - International Ethical Laboratories, Inc. (091176933) |
Registrant - Great Southern Laboratories (056139553) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Great Southern Laboratories | 056139553 | manufacture |
Revised: 03/2012 International Ethical Laboratories, Inc.