Label: CETIRIZINE HYDROCHLORIDE tablet, chewable
- NDC Code(s): 47335-343-83, 47335-343-88, 47335-344-83, 47335-344-88
- Packager: Sun Pharmaceutical Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 11, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding:
- Keep out of reach of children
-
Directions
- may be taken with or without water
- chew or crush tablets completely before swallowing
For 5 mg:
adults and children 6 years and over1 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
For 10 mg:
adults and children 6 years and over
Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet
(10 mg) 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
- Other information
-
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor
- Questions?
-
Principal Display Panel
For 5 mg Allergy:
Original Prescription Strength
NDC 47335-343-83
Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs. & older
30 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
For 10 mg Allergy:
Original Prescription Strength
NDC 47335-344-83
Cetirizine Hydrochloride Chewable Tablets
10 mg
ALLERGY
Antihistamine
Indoor + Outdoor Allergies
Actual Size
Tutti-frutti Flavor
No Water Needed
30 CHEWABLE TABLETS
SUN PHARMA
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47335-343 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) CROSPOVIDONE (UNII: 68401960MK) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) GUAR GUM (UNII: E89I1637KE) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PURPLE Score no score Shape ROUND Size 8mm Flavor TUTTI FRUTTI Imprint Code 343 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-343-83 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2011 2 NDC:47335-343-88 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090142 09/09/2011 CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47335-344 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) CROSPOVIDONE (UNII: 68401960MK) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) GUAR GUM (UNII: E89I1637KE) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PURPLE Score no score Shape ROUND Size 10mm Flavor TUTTI FRUTTI Imprint Code 344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-344-83 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2011 2 NDC:47335-344-88 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090142 09/09/2011 Labeler - Sun Pharmaceutical Industries, Inc. (146974886) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 725959238 ANALYSIS(47335-343, 47335-344) , MANUFACTURE(47335-343, 47335-344)