ALLERGY RELIEF- cetirizine hcl tablet

Allergy Relief by

Drug Labeling and Warnings

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

Warning

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
• 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.

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 (1-800-222-1222) right away.

Directions

• Adults and children 6 years and over: One 10 mg tablet 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 20o- 25o C (68o to 77o F)
• contains no ingredient made from a gluten-containing grain (wheat, barley or rye)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

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

Principal Display Panel

*Compare to the active ingredient in Zyrtec®

ALLERGY RELIEF

Cetirizine HCI

Antihistamine

10 mg tablets

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL ROAD,

MEMPHIS, TN 38118

www.fredsinc.com

Product Label

FRED'S PHARMACY Allergy Relief

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
cetirizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-806
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	G;4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-806-05	5 in 1 CARTON	02/28/2019
1		1 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	ANDA209274	02/28/2019

Labeler - Freds Inc (005866116)