DESPEC- dextromethorphan hydrobromide, guaifenesin, phenyllephrine hydrochloride liquid

DESPEC by

Drug Labeling and Warnings

DESPEC by is a Otc medication manufactured, distributed, or labeled by INTERNATIONAL ETHICAL LABS, WOODFIELD PHARMACEUTICAL, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active ingredients Purpose

(in each 5 mL teaspoonful)

Dextromethorphan

Hydrobromide 10 mg ................ Antitussive

Guaifenesin 100 mg ................ Expectorant

Phenylephrine

Hydrochloride 5 mg .... Nasal Decongestant

Purpose

Antitussive

Expectorant

Nasal Decongestant

Indications & Usage

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

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.

If pregnant or breast-feeding, ask a health

professional before use.

Ask a doctor

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

Stop use

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

Keep out of reach of children

In case of overdose, get medical help or

contact a Poison Control Center right away.

Dosage & Administration

Do not exceed recommended dosage.

Use with enclosed dosage cup.

Adults and Children

12 years of age and

over:

Children 6 to under

12 years of age:

Children under 6

years of age:

2 teaspoonfuls (2 TSP)

every 4 hours, not to

exceed 6 doses in

24 hours.

1 teaspoonful (1 TSP)

every 4 hours, not to

exceed 6 doses in

24 hours.

Consult a doctor.

Other safety information

Other information

Store at 59° - 86° F (15° - 30° C)

Inactive ingredient

citric acid, glycerin, grape flavor,

maltitol, propylene glycol, purified water,

sodium citrate, sodium saccharin, and

sorbitol.

Questions? Comments?

Questions? Comments?

Call 1-787-765-3510.

Manufactured for:

International Ethical Laboratories

San Juan PR 00918-2627

Manufactured by:

Woodfield Pharmaceutical, LLC

Houston, TX 77099

Rev. 09/15

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DESPEC 
dextromethorphan hydrobromide, guaifenesin, phenyllephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11584-1047
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11584-1047-6	1 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/11/2016

Labeler - INTERNATIONAL ETHICAL LABS (091176933)

Establishment
Name	Address	ID/FEI	Business Operations
WOODFIELD PHARMACEUTICAL, LLC		079398730	manufacture(11584-1047)