OTC Medication Information: L-Oral ALLERGEX Hay Fever and Allergy Relief Syrup

L-ORAL ALLERGEX HAY FEVER AND ALLERGY RELIEF SYRUP- diphenhydramine hydrochloride syrup
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

ACTIVE INGREDIENT (IN EACH 5 ML)

Diphenhydramine HCl 12.5 mg

PURPOSE

Antihistamine

USES

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

WARNINGS

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

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

DIRECTIONS

• 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

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

• 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?

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

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

L-ORAL ALLERGEX HAY FEVER AND ALLERGY RELIEF SYRUP diphenhydramine hydrochloride syrup

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-023 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN METHYLPARABEN SODIUM PROPYLPARABEN SODIUM SODIUM BENZOATE SUCRALOSE SORBITOL CITRIC ACID MONOHYDRATE D&C RED NO. 33 FD&C RED NO. 40 WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73921-023-04 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (73921-023-04)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2021

Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture (73921-023)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED