Label: CETIRIZINE HYDROCHLORIDE solution
Contains inactivated NDC Code(s)
NDC Code(s): 50090-4173-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 45802-974
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 22, 2019
If you are a consumer or patient please visit this version.
- Active ingredient (in each 5 mL)
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.
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
- use only with enclosed dosing cup
- find right dose on chart below
- mL = milliliter
adults and children
6 years and over
5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years
5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under
6 years of age
2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- cetirizine hydrochloride
INGREDIENTS AND APPEARANCE
cetirizine hydrochloride solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4173(NDC:45802-974) 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 in 5 mL Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM ACETATE (UNII: 4550K0SC9B) SUCROSE (UNII: C151H8M554) Product Characteristics Color YELLOW (Pale Yellow) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-4173-0 1 in 1 CARTON 03/07/2019 1 118 mL 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 ANDA090254 04/15/2008 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4173)