Label: ALL DAY ALLERGY RELIEF- cetirizine hcl capsule
- NDC Code(s): 63868-433-25
- Packager: CHAIN DRUG MARKETING ASSOCIATION INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 29, 2022
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
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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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- 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.
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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?
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SPL UNCLASSIFIED SECTION
*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Zyrtec ®.
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 248-449-9300
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
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Principal Display Panel
QC ®
QUALITY CHOICE
NDC 63868-433-25
*Compare to the Active Ingredient in Zyrtec®
All Day Allergy Relief
Cetirizine HCl Capsules, 10 mg
Antihistamine
Indoor & Outdoor
Allergies
24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
25 softgels**
(**Liquid-Filled Capsules)
Front
Back
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INGREDIENTS AND APPEARANCE
ALL DAY ALLERGY RELIEF
cetirizine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-433 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 FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange Score no score Shape OVAL Size 13mm Flavor Imprint Code CE1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-433-25 1 in 1 BOX 01/25/2019 1 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022429 01/25/2019 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(63868-433)