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NDC 43598-0735-80 levocetirizine dihydrochloride 5 mg/1 Details

levocetirizine dihydrochloride 5 mg/1

levocetirizine dihydrochloride is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Inc.. The primary component is LEVOCETIRIZINE DIHYDROCHLORIDE.

MedlinePlus Drug Summary

Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other substances such as dust mites, animal dander, and mold. It is also used to treat symptoms of hives, including itching and rash. Levocetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 43598-0735-80
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levocetirizine

Product Information

NDC	43598-0735
Product ID	43598-735_edb4b4ba-4dd4-93b3-d23f-29d2caeccadb
Associated GPIs	41550027100320
GCN Sequence Number	048920
GCN Sequence Number Description	levocetirizine dihydrochloride TABLET 5 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	14901
HICL Sequence Number	022959
HICL Sequence Number Description	LEVOCETIRIZINE DIHYDROCHLORIDE
Brand/Generic	Generic
Proprietary Name	levocetirizine dihydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	levocetirizine dihydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LEVOCETIRIZINE DIHYDROCHLORIDE
Labeler Name	Dr. Reddy's Laboratories Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210375
Listing Certified Through	2024-12-31

Package

Package Images

NDC 43598-0735-80 (43598073580)

Pricing Information	N/A
NDC Package Code	43598-735-80
Billing NDC	43598073580
Package	1 BOTTLE in 1 CARTON (43598-735-80) / 80 TABLET, COATED in 1 BOTTLE
Marketing Start Date	2018-03-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1f722b84-08de-7e6a-41ac-2c9d9bb9fb43 Details

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP, 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

Do not use

if you have kidney disease
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

ever had trouble urinating or emptying your bladder

When using this product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

you have trouble urinating or emptying your bladder
an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feding: not recommended
if pregnant: ask a health professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

adults 65 years of age and older	ask a doctor
adults and children 12-64 years of age	take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age	do not use
consumers with kidney disease	do not use

Other information

store between 20° and 25°C (68° and 77°F)
(bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(blister only) safety sealed: do not use if seal is broken or if individual blister unit is open or torn

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

Call 1-888-375-3784

Levocetirizine Dihydrochloride Tablets, USP 5 mg carton label

Dr. Reddy's

NDC 43598-735-35

Original Prescription Strength

Levocetirizine

Dihydrochloride

Tablets USP, 5 mg

Antihistamine

ALLERGY

24 HOUR

Relief of:

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

35 Tablets

Levocetirizine Dihydrochloride Tablets USP, 5 mg bottle label

NDC 43598-735-35

Dr.Reddy's

Original Prescription Strength

Levocetirizine

Dihydrochloride Tablets USP, 5 mg

Antihistamine