FDA.reportPublic FDA data

Glentuss

Manufacturer
Glendale Inc
Effective date
2015-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:24

Label at a glance#

ProductGlentuss
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and 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 runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion temporarily restores freer breathing through the nose congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed 4 dosage in a 24-hour period. Adults and children 12 years of age and over: 2 teaspoonfuls every 6 hours Children under 12 years of age: Consult a physician

Storage and handling

Store at 59°-86°F (15°-30°C) [see USP for Controlled Room Temperature]

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each teaspoonful)Purpose
Dextromethorphan Hydrobromide 15 mgAntitussive (cough suppressant)
Pseudoephedrine Hydrochloride 30 mgNasal Decongestant
Doxylamine Succinate 6.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

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
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • temporarily restores freer breathing through the nose congestion
  • reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

  • to sedate a child or make a child sleepy
  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occur with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed 4 dosage in a 24-hour period.

Adults and children 12 years of age and over:2 teaspoonfuls every 6 hours
Children under 12 years of age:Consult a physician

Other information

STORAGE AND HANDLING SECTION

Store at 59°-86°F (15°-30°C) [see USP for Controlled Room Temperature]

Inactive ingredients

INACTIVE INGREDIENT SECTION

Apple candy flavor, citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

Questions? Comments?

OTC - QUESTIONS SECTION

To report a serious adverse event or obtain product information, Call 1-630-530-7000.

SPL UNCLASSIFIED SECTION

Distributed by:
Glendale Inc
Villa, Park, IL 60181

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70147-0233-16

Glentuss

Antitussive
Nasal Decongestant
Antihistamine

Each teaspoonful for oral
administration contains:
Dextromethorphan HBr 15 mg
Pseudoephedrine HCl 30 mg
Doxylamine Succinate 6.25 mg

SUGAR FREE / DYE FREE
ALCOHOL FREE

Apple Candy Flavored Liquid

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Distributed by:
Glendale Inc
Villa Park, IL 60181

16 fl oz. (473 mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094350dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN1
1094350dextromethorphan hydrobromide 3 MG/ML / doxylamine succinate 1.25 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD1
1094350dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70147-233-162020-01-31C16284748780-19d75b9d1-02d0-f424-e053-dadaa90a57ceGlentuss

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70147-233-16Glentuss473 mL in 1 BOTTLE, PLASTICSYRUP4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70147-233GLENTUSS (DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) SYRUP [GLENDALE INC]1Legacy NDC, 1 package rows20151217_8a6eb670-8bed-4941-b4fd-70b3f1e48401.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70147-233-16ML - Milliliter70147-23382e5b57f-8188-469a-88b8-f4890c825f6c12016-11-08

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70147-23370147-233-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT

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
f23182eb-a618-4556-a265-3de318cc7ae58a6eb670-8bed-4941-b4fd-70b3f1e484012015-12-09WarningsExact identifier
spl id: f23182eb-a618-4556-a265-3de318cc7ae5
spl set id: 8a6eb670-8bed-4941-b4fd-70b3f1e48401

Reported adverse events (FAERS/openFDA)#

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