CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF- cetirizine hydrochloride tablet

Cetirizine HCL 10 mg All Day Allergy Relief by

Drug Labeling and Warnings

Cetirizine HCL 10 mg All Day Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

 Cetirizine HCl 10 mg

Purpose

 Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose      
• sneezing      
• itchy, watery eyes
• itching of the nose or throat

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.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

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 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.

Directions

• adults and children 6 years and over: Take one 10 mg table once daily; do not take more than one 10 mg tablet 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)

Inactive ingredients

lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, and titanium dioxide

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

All Day Allergy Relief

Cetirizine HCl, 10 mg Tablets

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

Tablets

Compare to the active ingredient in Zyrtec®**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Zyrtec®.

Product of USA

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE.  USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Fred's All Day Allergy Relief Tablets

 

INGREDIENTS AND APPEARANCE

CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-129
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	IP46
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-129-30	2 in 1 CARTON	03/01/2013	12/30/2021
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078780	03/01/2013	12/30/2021

Labeler - Freds Inc (005866116)