<<

NDC 0228-1196-55 Active ingredient (in each ) Purpose Cetirizine HCl 5 mg ...... Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: N runny nose N sneezing N itchy, watery eyes N itching of the nose or Cetirizine throat Hydrochloride Warnings Do not use if you have ever had an allergic Tablets 5 mg reaction to this product or any of its ingredients or to an Antihistamine antihistamine containing . Rev. 11/07 Allergy Mfd by: Shasun Chemical & Drugs Limited, Indoor & Outdoor Allergies Unit II, R.S. No.: 32, 33, & 34, PIMS Road, Periyakalapet, Pondicherry – 605014. India

100 tablets - 5 mg each or missing. on bottle is broken For: Actavis Elizabeth LLC, 200 Elmora Avenue PEEL

Do not use if imprinted foil inner seal foil Do not use if imprinted Elizabeth, NJ 07207 USA HERE

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. When using this product N drowsiness may occur N avoid alcoholic drinks N , sedatives, and tranquilizers may increase drowsiness N 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: N if breast-feeding: not recommended N 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 N 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. N adults 65 years and over: 1 tablet once a day; do not take more than 1 tablet in 24 hours. N children under 6 years of age: ask a doctor N consumers with liver or kidney disease: ask a doctor Other information N store between 20° to 25°C (68° to 77°F) N do not use if imprinted foil inner seal on bottle is broken or missing. Inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, triacetin and titanium dioxide. Questions? call 1-800-432-8534 Rev. 11/07 Mfd by: Shasun Chemical & Drugs Limited, Unit II, R.S. No.: 32, 33, & 34, PIMS Road, Periyakalapet, Pondicherry – 605014. India For: Actavis Elizabeth LLC, 200 Elmora Avenue Elizabeth, NJ 07207 USA NDC 0228-1198-55 Active ingredient (in each tablet) Purpose Cetirizine HCl 10 mg ...... Antihistamine Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: N runny nose N sneezing N itchy, watery eyes N itching of the nose or Cetirizine throat Hydrochloride Warnings Do not use if you have ever had an allergic Tablets 10 mg reaction to this product or any of its ingredients or to an Antihistamine antihistamine containing hydroxyzine. Rev. 11/07 Allergy Mfd by: Shasun Chemical & Drugs Limited, Indoor & Outdoor Allergies Unit II, R.S. No.: 32, 33, & 34, PIMS Road, Periyakalapet, Pondicherry – 605014. India

100 tablets -10 mg each or missing. on bottle is broken For: Actavis Elizabeth LLC, 200 Elmora Avenue PEEL

Do not use if imprinted foil inner seal foil Do not use if imprinted Elizabeth, NJ 07207 USA HERE

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. When using this product N drowsiness may occur N avoid alcoholic drinks N alcohol, sedatives, and tranquilizers may increase drowsiness N 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: N if breast-feeding: not recommended N 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 N 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. N adults 65 years and over: ask a doctor N children under 6 years of age: ask a doctor N consumers with liver or kidney disease: ask a doctor Other information N store between 20° to 25°C (68° to 77°F) N do not use if imprinted foil inner seal on bottle is broken or missing. Inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, triacetin and titanium dioxide. Questions? call 1-800-432-8534 Rev. 11/07 Mfd by: Shasun Chemical & Drugs Limited, Unit II, R.S. No.: 32, 33, & 34, PIMS Road, Periyakalapet, Pondicherry – 605014. India For: Actavis Elizabeth LLC, 200 Elmora Avenue Elizabeth, NJ 07207 USA

Indoor & Outdoor Allergies Outdoor & Indoor

Allergy

Antihistamine

5 mg 5 Tablets

Hydrochloride Cetirizine

Original Prescription Drug Facts (continued) Drug Facts (continued) NEW Strength Drug Facts When using this product Directions NDC 0228-1196-55 drowsiness may occur Active ingredient Purpose N adults and children 1 to 2 tablets once N avoid alcoholic drinks (in each tablet) 6 years and over daily depending upon N alcohol, sedatives, and tranquilizers may Cetirizine HCl 5 mg...... Antihistamine increase drowsiness severity of symptoms; Compare to the do not take more than N be careful when driving a motor vehicle or active ingredient Uses operating machinery 2 tablets in 24 hours in Zyrtec Allergy temporarily relieves these symptoms due to ® * hay fever or other upper respiratory allergies Stop use and ask a doctor if an allergic adults 65 years 1 tablet once a day; do and over runny nose sneezing reaction to this product occurs. Seek medical not take more than N N itchy, watery eyes help right away. 1 tablet in 24 hours Cetirizine N children under ask a doctor Hydrochloride Nitching of the nose or throat If pregnant or breast-feeding: 6 years of age Tablets N if breast-feeding: not recommended 5 mg Warnings consumers with liver ask a doctor N if pregnant: ask a health professional before use. Antihistamine Do not use if you have ever had an allergic Keep out of reach of children. In case of or kidney disease reaction to this product or any of its ingredients overdose, get medical help or contact a Poison Other information Allergy or to an antihistamine containing hydroxyzine. Control Center right away. N Store between 20° to 25°C (68° to 77°F) Indoor & Outdoor Allergies Ask a doctor before use if you have N do not use if imprinted foil inner seal on bottle liver or kidney disease. Your doctor should *This product is not manufactured or distributed by is broken or missing. 24 hour Relief of determine if you need a different dose. Johnson & Johnson, distributor of Zyrtec®. • Sneezing • Runny Nose Rev. 11/07 Inactive ingredients colloidal silicon Itchy, Watery Eyes Ask a doctor or pharmacist before use • if you are taking tranquilizers or sedatives. Mfd by: Shasun Chemical & Drugs Limited, dioxide, crospovidone, hypromellose, lactose Unit II, R.S. No.: 32, 33, & 34, PIMS Road, Periyakalapet, • Itchy Throat or Nose Pondicherry – 605014. India monohydrate, magnesium stearate, microcrystalline For: Actavis Elizabeth LLC, 200 Elmora Avenue cellulose, triacetin and titanium dioxide. Elizabeth, NJ 07207 USA 100 tablets - 5 mg each

Indoor & Outdoor Allergies Outdoor & Indoor

Allergy

Antihistamine

10 mg 10 Tablets

Hydrochloride Cetirizine

Original Prescription Drug Facts (continued) Drug Facts (continued) NEW Strength Drug Facts When using this product Directions NDC 0228-1198-55 N drowsiness may occur Active ingredient Purpose avoid alcoholic drinks adults and children one 10 mg tablet once N 6 years and over daily; do not take more (in each tablet) N alcohol, sedatives, and tranquilizers may than one 10 mg tablet in Cetirizine HCl 10 mg...... Antihistamine increase drowsiness 24 hours. A 5 mg product Compare to the N be careful when driving a motor vehicle or may be appropriate for active ingredient Uses operating machinery less severe symptoms. in Zyrtec Allergy temporarily relieves these symptoms due to ® * hay fever or other upper respiratory allergies Stop use and ask a doctor if an allergic adults 65 years ask a doctor runny nose sneezing reaction to this product occurs. Seek medical N N and over itchy, watery eyes help right away. Cetirizine N children under ask a doctor Hydrochloride Nitching of the nose or throat If pregnant or breast-feeding: 6 years of age Tablets N if breast-feeding: not recommended 10 mg Warnings consumers with liver ask a doctor N if pregnant: ask a health professional before use. Antihistamine Do not use if you have ever had an allergic Keep out of reach of children. In case of or kidney disease reaction to this product or any of its ingredients overdose, get medical help or contact a Poison Other information Allergy or to an antihistamine containing hydroxyzine. Control Center right away. N Store between 20° to 25°C (68° to 77°F) Indoor & Outdoor Allergies Ask a doctor before use if you have N do not use if imprinted foil inner seal on bottle liver or kidney disease. Your doctor should *This product is not manufactured or distributed by is broken or missing. 24 hour Relief of determine if you need a different dose. Johnson & Johnson, distributor of Zyrtec®. • Sneezing • Runny Nose Rev. 11/07 Inactive ingredients colloidal silicon Itchy, Watery Eyes Ask a doctor or pharmacist before use • if you are taking tranquilizers or sedatives. Mfd by: Shasun Chemical & Drugs Limited, dioxide, crospovidone, hypromellose, lactose Unit II, R.S. No.: 32, 33, & 34, PIMS Road, Periyakalapet, • Itchy Throat or Nose Pondicherry – 605014. India monohydrate, magnesium stearate, microcrystalline For: Actavis Elizabeth LLC, 200 Elmora Avenue cellulose, triacetin and titanium dioxide. Elizabeth, NJ 07207 USA 100 tablets - 10 mg each

Indoor & Outdoor Allergies Outdoor & Indoor

Allergy

Antihistamine

10 mg 10 Tablets

Hydrochloride Cetirizine

NEW Original Prescription NDC 0228-1198-57 Strength Drug Facts Drug Facts(continued) Drug Facts(continued) Compare to the Active ingredient Purpose When using this product Other information active ingredient (in each tablet) N drowsiness may occur N avoid alcoholic drinks N Store between 20° to 25°C (68° to 77°F) in Zyrtec Allergy N alcohol, sedatives, and tranquilizers may increase drowsiness N do not use if imprinted foil inner seal on ® * Cetirizine HCl 10 mg...... Antihistamine N be careful when driving a motor vehicle or operating machinery bottle is broken or missing. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. Uses Inactive ingredients colloidal silicon Cetirizine temporarily relieves these symptoms due to If pregnant or breast-feeding: hay fever or other upper respiratory allergies: dioxide, crospovidone, hypromellose, lactose N if breast-feeding: not recommended Hydrochloride runny nose sneezing monohydrate, magnesium stearate, N N N if pregnant: ask a health professional before use. itchy, watery eyes microcrystalline cellulose, triacetin and Tablets 10 mg N Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right titanium dioxide. Nitching of the nose or throat away. Antihistamine Warnings Directions Do not use if you have ever had an allergic *This product is not manufactured or distributed by reaction to this product or any of its ingredients adults and children one 10 mg tablet once daily; do not take more than one 10 mg tablet Johnson & Johnson, distributor of Zyrtec®. Allergy or to an antihistamine containing hydroxyzine. 6 years and over in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Rev. 11/07 Indoor & Outdoor Allergies Ask a doctor before use if you have adults 65 years and over ask a doctor liver or kidney disease. Your doctor should 24 hour Relief of children under determine if you need a different dose. ask a doctor • Sneezing • Runny Nose 6 years of age Mfd by: Shasun Chemical & Drugs Limited, Ask a doctor or pharmacist before use Unit II, R.S. No.: 32, 33, & 34, PIMS Road, Periyakalapet, Itchy, Watery Eyes Itchy Throat or Nose consumers with liver Pondicherry – 605014. India • • if you are taking tranquilizers or sedatives. or kidney disease ask a doctor For: Actavis Elizabeth LLC, 200 Elmora Avenue Elizabeth, NJ 07207 USA 200 tablets 10 mg each – Contains 2 bottles of 100 tablets each