CETIRIZINE HYDROCHLORIDE
-
cetirizine hydrochloride tablet
Torrent Pharmaceuticals Limited
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Cetirizine HydrochlorideDrug Facts:
Active ingredient (in each tablet)
Cetirizine HCl 5 mg
For 10 mg:
Cetirizine HCl 10 mg
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Do not use 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.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
- 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.
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.
For 5 mg:
| 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
|
| adults and children 6 years and over | one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
| adults 65 years and over | ask a doctor |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
• 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
TORRENT PHARMACEUTICALS LTD.
Indrad-382 721, Dist. Mehsana, INDIA.
PRINCIPAL DISPLAY PANEL – 5 mg Allergy
NDC 13668-029-30
Cetirizine HCl Tablets 5 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Tamper Evident:
Do not use if imprinted inner safety seal is torn or missing.
PRINCIPAL DISPLAY PANEL – 10 mg Allergy
NDC 13668-030-30
Cetirizine HCl Tablets 10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Tamper Evident:
Do not use if imprinted inner safety seal is torn or missing.
Drug Facts:
Active ingredient (in each tablet)
Cetirizine HCl 5 mg
For 10 mg:
Cetirizine HCl 10 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.
• 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.
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- 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
For 5 mg:
| 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
|
| adults and children 6 years and over | One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
| adults 65 years and over
| ask a doctor |
| children under 6 years of age
| ask a doctor
|
| consumers with liver or kidney disease | ask a doctor
|
• 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
call 1-269-544-2299 weekdays
TORRENT PHARMACEUTICALS LTD.
Indrad-382 721, Dist. Mehsana, INDIA.
PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief
NDC 13668-029-30
Cetirizine HCl Tablets 5 mg
Antihistamine
Hives Relief
24 Hour Relief of Itching Due to Hives
30 Tablets 5 mg each
Tamper Evident:
Do not use if imprinted inner safety seal is torn or missing.
PRINCIPAL DISPLAY PANEL – 10 mg Hives Relief
NDC 13668-030-30
Cetirizine HCl Tablets 10 mg
Antihistamine
Hives Relief
24 Hour Relief of Itching Due to Hives
30 Tablets 10 mg each
Tamper Evident:
Do not use if imprinted inner safety seal is torn or missing.
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA079191 | 04/15/2010 | |
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA079191 | 04/15/2010 | |
| Labeler - Torrent Pharmaceuticals Limited (650175722) |