L-Oral ALLERGEX Hay Fever and Allergy Relief Syrup

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-26
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 ALLERGEX Hay Fever and Allergy Relief Syrup
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• Relieves symptoms due to hay fever or other upper respiratory allergies • Sneezing • Runny nose • Itchy, watery eyes • Itching of the nose or throat

Dosage and administration

• Do not take more than 6 doses in 24 hours • Take every 4 to 6 hours, or as directed by a doctor • Measure only with dosing cup provided. Do not use any other dosing device. • mL=milliliter • Keep dosing cup with product • Find the right dose on the chart below Age (yr)                              Dose (mL) Children 6 to 11 years         5 mL to 10 mL Children 2 to 5 years           Do not use unless directed by...

Storage and handling

• Each 5 mL contains: Sodium 0.03 mg • Store between 20-25°C (68-77°F). Do not refrigerate. • Protect from light. Store in outer carton until contents are used.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH 5 ML)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USES

INDICATIONS & USAGE SECTION

• Relieves symptoms due to hay fever or other upper respiratory allergies • Sneezing • Runny nose • Itchy, watery eyes • Itching of the nose or throat

WARNINGS

WARNINGS SECTION

Do not use

• With any other product containing diphenhydramine, even one used on the skin • To make a child sleepy

Ask a doctor before use if the child has • Breathing problem such as chronic bronchitis • Glaucoma • Sodium-restricted diet

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

When using this product • Marked drowsiness may occur • Sedatives and tranquilizers may increase drowsiness • Excitability may occur, especially in children

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 take more than 6 doses in 24 hours • Take every 4 to 6 hours, or as directed by a doctor • Measure only with dosing cup provided. Do not use any other dosing device. • mL=milliliter • Keep dosing cup with product • Find the right dose on the chart below

Age (yr)                              Dose (mL)

Children 6 to 11 years         5 mL to 10 mL

Children 2 to 5 years           Do not use unless directed by a doctor

Children under 2 years        Do not use

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycerin, Methylparaben Sodium, Propylparaben Sodium, Sodium Benzoate, Sucralose, sorbitol, Citric acid monohydrate, D&C red #33, FD&C red #40, flavor & purified water.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• Each 5 mL contains: Sodium 0.03 mg • Store between 20-25°C (68-77°F). Do not refrigerate. • Protect from light. Store in outer carton until contents are used.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

SPL UNCLASSIFIED SECTION

Relieves: • Itchy Throat/Nose • Itchy, Watery Eyes • Sneezing • Runny Nose

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

Syrup23Syrup23

FDA-Initiated Inactive NDC Indexing#

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-02373921-023-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f42b2912-24a6-7619-e053-2a95a90ae1ba17c0386c-6e8a-40cf-8c0d-932f04e083852023-02-08WarningsExact identifier
spl set id: 17c0386c-6e8a-40cf-8c0d-932f04e08385

Reported adverse events (FAERS/openFDA)#

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