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#
Contacts and useful links#
Label contents#
Full prescribing information#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1044949 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution | PSN | 3 |
| 1044949 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 3 |
| 1044949 | dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 3 |
| 1044949 | dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11584-1047-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-48e8-f424-e053-dadaa90a57ce | DESPEC DM-G |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11584-1047-6 | DESPEC | 1 mL in 1 BOTTLE | LIQUID | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11584-1047 | DESPEC (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] | 3 | Legacy NDC, 1 package rows | 20181020_65d116e7-8963-0b01-e053-2a91aa0abac0.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11584-1047-6 | ML - Milliliter | 11584-1047 | b098a440-7fae-4eab-b5a9-2a1455faf610 | 1 | 2018-03-08 |
Products#
Every source-derived product name is available through these pages.
- DESPEC
- Dextromethorphan Hydrobromide, Guaifenesin, Phenyllephrine Hydrochloride
- GLYCERIN
- MALTITOL
- DIPROPYLENE GLYCOL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11584-1047 | 11584-1047-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| MALTITOL | D65DG142WK | IACT |
| DIPROPYLENE GLYCOL | E107L85C40 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 78727a73-e7aa-bef6-e053-2a91aa0aa4a3 | 65d116e7-8963-0b01-e053-2a91aa0abac0 | 2018-10-17 | Warnings | 78727a73-e7aa-bef6-e053-2a91aa0aa4a3 65d116e7-8963-0b01-e053-2a91aa0abac0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
