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 | ||||||||||||||||||||||||
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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
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/l-oral-allergex-hay-fever-and-allergy-relief-syrup/