DESPEC DM- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

DESPEC by

Drug Labeling and Warnings

DESPEC by is a Otc medication manufactured, distributed, or labeled by International Ethical Laboratories, Inc, Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

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.

INACTIVE INGREDIENT

Inactive Ingredients citric acid, glycerin, grape flavor, maltitol, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

PURPOSE

Uses

Temporarily relieves these symptoms due to the common cold, high 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

ACTIVE INGREDIENT

Active Ingredient Purpose

(in each 5mL teaspoonful)

Dextromethorphan Hydrobromide 15mg…. Antitussive

Guaifenesin 100mg ………………………… Expectorant

Phenylephrine Hydrochloride 5mg ……….. Decongestant

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of accidental over dose seek professional help or contact a Poison Control Center immediately.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

Uses

Temporarily relieves these symptoms due to the common cold, high 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 congestionreduces swelling of nasal

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DESPEC  DM
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11584-1046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11584-1046-5	6 in 1 CARTON	02/19/2014
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 11584-1046-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/19/2014

Labeler - International Ethical Laboratories, Inc. (091176933)

Registrant - Woodfield Pharmaceutical, LLC (079398730)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(11584-1046)