Label: INDOOR/OUTDOOR ALLERGY RELIEF SOFTGELS- cetirizine hydrochloride capsule
- NDC Code(s): 59779-415-25, 59779-415-30, 59779-415-40
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient (in each capsule)
Cetirizine HCl 10 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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 reation 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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
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
- store between 20°-25°C (68°-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
- Inactive ingredients
FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitolClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Compare to the active ingredient in ZYRTEC®*
Original Prescription Strength
24 HOUR Symptom Relief
INDOOR & OUTDOOR ALLERGY RELIEF
CETIRIZINE HYDROCHLORIDE SOFTGELS 10 mg / ANTIHISTAMINE
24 hour relief of:
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark ZYRTEC®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
- Package Label
CVS Pharmacy Indoor & Outdoor Allergy ReliefClose
- INGREDIENTS AND APPEARANCE
INDOOR/OUTDOOR ALLERGY RELIEF SOFTGELS
cetirizine hydrochloride capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-415 Route of Administration ORAL DEA Schedule 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 GLYCOLS (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 7mm Flavor Imprint Code CET Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-415-30 1 in 1 PACKAGE 1 30 in 1 BOTTLE, PLASTIC 2 NDC:59779-415-25 1 in 1 PACKAGE 2 25 in 1 BOTTLE, PLASTIC 3 NDC:59779-415-40 1 in 1 PACKAGE 3 40 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022429 03/01/2013 Labeler - CVS Pharmacy (062312574)