drug facts
78ff8e86-ee5b-4626-aa81-49e974febf1d
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Antihistamine
Description
Levocetirizine dihydrochloride USP 5 mg
Medication Information
Active Ingredient
Levocetirizine dihydrochloride USP 5 mg
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
Purpose
Antihistamine
Directions
| adults 65 years of age and older
|
|
| adults and children 12-64 years of age
|
|
| children 6-11 years of age
|
|
| children under 6 years of age
|
|
| consumers with kidney disease
|
|
Inactive Ingredients
hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide
Description
Levocetirizine dihydrochloride USP 5 mg
Principal Display Panel
MICRO LABS LIMITED
Container
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
Container-Carton
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
INVATECH PHARMA SOLUTIONS LLC
Container
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
Container-Carton
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
Storage
- store between 20° and 25°C (68° and 77°F)
- safety sealed: do not use if carton was opened or torn
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
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
Questions Or Comments?
call 1-855-839-8195
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 A 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-feeding: 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).
Ask A Doctor Before Use If You Have
- ever had trouble urinating or emptying your bladder
Structured Label Content
Active Ingredient (Active ingredient (in each tablet))
Levocetirizine dihydrochloride USP 5 mg
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
Purpose
Antihistamine
Directions (DIRECTIONS)
| adults 65 years of age and older
|
|
| adults and children 12-64 years of age
|
|
| children 6-11 years of age
|
|
| children under 6 years of age
|
|
| consumers with kidney disease
|
|
Inactive Ingredients (Inactive ingredients)
hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
MICRO LABS LIMITED
Container
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
Container-Carton
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
INVATECH PHARMA SOLUTIONS LLC
Container
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
Container-Carton
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine
90 Tablets MICRO LABS
Storage (STORAGE)
- store between 20° and 25°C (68° and 77°F)
- safety sealed: do not use if carton was opened or torn
Do Not Use (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
Do Not Use (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
Questions Or Comments? (Questions or comments?)
call 1-855-839-8195
When Using This Product (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 A Doctor If (Stop use and ask a 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 pregnant or breast-feeding:)
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use
Keep Out of Reach of Children. (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).
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- ever had trouble urinating or emptying your bladder
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:05:35.266130 · Updated: 2026-03-14T23:07:36.685051