L-Oral COUGH RELIEF Syrup

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:45:43

Label at a glance#

ProductL-Oral COUGH RELIEF Syrup
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

• Temporarily relieves cough • Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Dosage and administration

• Take every 4 hours • Do not exceed 6 doses in 24 hours  Age  Dose  Adults & children 12 years & over  10 mL (2 teaspoonfuls)  Children 6 years to under 12 years  5 mL (1 teaspoonful)  Children 2 years to under 6 years  2.5 mL (1/2 teaspoonful)  Children under 2 years  Ask a doctor How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the ...

Storage and handling

Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (1 teaspoonful) contains:
Dextromethorphan HBr  
Guaifenesin  

PURPOSE

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acesulfame potassium, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

USES

INDICATIONS & USAGE SECTION

• Temporarily relieves cough

• Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

WARNINGS

WARNINGS SECTION

Do not use
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 two 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
• A cough that occur with too much phlegm (mucus)
• A chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if
• A cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
• These could be signs of a serious condition.

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.

Professional note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Take every 4 hours
• Do not exceed 6 doses in 24 hours

 Age Dose
 Adults & children 12 years & over 10 mL (2 teaspoonfuls)
 Children 6 years to under 12 years 5 mL (1 teaspoonful)
 Children 2 years to under 6 years 2.5 mL (1/2 teaspoonful)
 Children under 2 years Ask a doctor

How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Storage:

STORAGE AND HANDLING SECTION

Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST.

SPL UNCLASSIFIED SECTION

Expectorant & Cough Relief

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loral29-2Loral29-2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-029-042023-02-08C16284748780-1f386c64a-2926-0266-e053-dadaa90a7c1aL-Oral COUGH RELIEF SYRUP
73921-029-042023-01-30C16284748780-1f386c64a-2926-0266-e053-dadaa90a7c1aL-Oral COUGH RELIEF SYRUP

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-02973921-029-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
f42c043a-6110-4b6c-e053-2995a90a1a0a18745c15-5075-4ead-b93c-f6e53e6dcdaf2023-02-08WarningsExact identifier
spl set id: 18745c15-5075-4ead-b93c-f6e53e6dcdaf

Reported adverse events (FAERS/openFDA)#

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