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.

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L-Oral ALLERGEX Hay Fever & Allergy Relief Syrup

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

Syrup23

L-ORAL ALLERGEX HAY FEVER AND ALLERGY RELIEF SYRUP 
diphenhydramine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73921-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73921-023-041 in 1 CARTON04/01/202102/08/2023
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-023)

Revised: 2/2023
 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED