DESPEC

Manufacturer
INTERNATIONAL ETHICAL LABS | WOODFIELD PHARMACEUTICAL, LLC
Effective date
2018-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:57:04

Label at a glance#

ProductDESPEC
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

(in each 5 mL teaspoonful)

Dextromethorphan

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

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

Phenylephrine

Hydrochloride 5 mg .... Nasal Decongestant

Purpose

OTC - PURPOSE SECTION

Antitussive

Expectorant

Nasal Decongestant

Indications & Usage

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or

contact a Poison Control Center right away.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

citric acid, glycerin, grape flavor,

maltitol, propylene glycol, purified water,

sodium citrate, sodium saccharin, and

sorbitol.

Questions? Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package label principal display panelPackage label principal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSN3
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD3
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY3
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11584-1047-62020-01-31C16284748780-19d75b9d0-48e8-f424-e053-dadaa90a57ceDESPEC DM-G

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11584-1047-6DESPEC1 mL in 1 BOTTLELIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11584-1047DESPEC (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS]3Legacy NDC, 1 package rows20181020_65d116e7-8963-0b01-e053-2a91aa0abac0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11584-1047-6ML - Milliliter11584-1047b098a440-7fae-4eab-b5a9-2a1455faf61012018-03-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11584-104711584-1047-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
78727a73-e7aa-bef6-e053-2a91aa0aa4a365d116e7-8963-0b01-e053-2a91aa0abac02018-10-17WarningsExact identifier
spl id: 78727a73-e7aa-bef6-e053-2a91aa0aa4a3
spl set id: 65d116e7-8963-0b01-e053-2a91aa0abac0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.