Cetirizine Tablets: Package Insert / Prescribing Information - Drugs.com

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# Cetirizine Tablets

Package insert / prescribing information
Generic name: cetirizine hydrochloride
Dosage form: tablet
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Jun 21, 2022.

Drug Facts:

Active ingredient (in each tablet)

Cetirizine HCl 5 mg

Purpose: Antihistamine

Uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

- trouble swallowing
- dizziness or loss of consciousness
- swelling of tongue
- trouble speaking
- swelling in or around mouth
- drooling
- wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

• to prevent hives from any known cause such as:

- foods
- insect stings
- medicines
- latex or rubber gloves

because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

- liver or kidney disease. Your doctor should determine if you need a different dose.
- hives that are an unusual color, look bruised or blistered
- hives that do not itch

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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

- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve after 3 days of treatment
- the hives have lasted more than 6 weeks

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.

Directions

adults and children 6 years and over | 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over | 1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age | ask a doctor
consumers with liver or kidney disease | ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

call 1-269-544-2299 weekdays

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

## PRINCIPAL DISPLAY PANEL

NDC 13668-029-04

Cetirizine HCl Tablets 5 mg

Antihistamine

Hives Relief

24 Hour Relief of Itching Due to Hives

500 Tablets 5 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride tablet

Product Information
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:13668-029
Route of Administration | ORAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) | CETIRIZINE HYDROCHLORIDE | 5 mg

Inactive Ingredients
Ingredient Name | Strength
COLLOIDAL SILICON DIOXIDE |
STARCH, CORN |
HYPROMELLOSE 2910 (6 CPS) |
LACTOSE MONOHYDRATE |
MAGNESIUM STEARATE |
POLYETHYLENE GLYCOL 400 |
POVIDONE K30 |
TALC |
TITANIUM DIOXIDE |

Product Characteristics
Color | WHITE (white to off-white) | Score | no score
Shape | ROUND (rounded-off,rectangular shaped, film coated tablet) | Size | 7mm
Flavor |  | Imprint Code | 5;29
Contains |

Packaging
# | Item Code | Package Description
1 | NDC:13668-029-06 | 30 TABLET (30 TABLET) in 1 BOTTLE
2 | NDC:13668-029-02 | 100 TABLET (100 TABLET) in 1 BOTTLE
3 | NDC:13668-029-03 | 250 TABLET (250 TABLET) in 1 BOTTLE
4 | NDC:13668-029-04 | 500 TABLET (500 TABLET) in 1 BOTTLE

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
ANDA | ANDA079191 | 04/15/2010 |

Labeler - Torrent Pharmaceuticals Limited (916488547)

Torrent Pharmaceuticals Limited

## Frequently asked questions

- Should cetirizine be taken at bedtime or upon awakening? And before or after any particular meal?
- Can you take antihistamines when pregnant?
- Is Generic Zyrtec Available?

View more FAQ

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