Label: TOPCARE ALL DAY ALLERGY- cetirizine hydrochloride capsule, liquid filled
- NDC Code(s): 36800-448-09, 36800-448-49, 36800-448-63
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
-
Warnings
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.
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.
-
Directions
adults and children 6 years and over
one 10 mg capsule once daily; do not take more than one 10 mg capsule 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
- Questions or comments?
-
Package/Label Principal Display Panel
TopCare® health
COMPARE TO ZYRTEC® LIQUID GELS ACTIVE INGREDIENT
ORIGINAL PRESCRIPTION STRENGTH
All Day Allergy
CETIRIZINE HYDROCHLORIDE CAPSULES 10 mg
ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIES
24 HOUR
RELIEF OF:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
65 LIQUID GELS**
actual size
** LIQUID FILLED CAPSULES
-
INGREDIENTS AND APPEARANCE
TOPCARE ALL DAY ALLERGY
cetirizine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-448 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color YELLOW Score no score Shape OVAL Size 13mm Flavor Imprint Code C10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-448-63 1 in 1 PACKAGE 02/28/2022 1 25 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:36800-448-09 1 in 1 PACKAGE 02/28/2022 2 65 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:36800-448-49 1 in 1 PACKAGE 02/03/2023 3 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213105 02/28/2022 Labeler - Topco Associates LLC (006935977)