INDOOR OUTDOOR ALLERGIES- cetirizine hcl tablet

Indoor outdoor allergies by

Drug Labeling and Warnings

Indoor outdoor allergies by is a Otc medication manufactured, distributed, or labeled by PLD Acquisitions LLC DBA Avéma Pharma Solutions. 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, sedative, 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 pregnant: ask a health professional before use
• If breast-feeding: not recommended

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: Take 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 to 25°C (68º to 77°F)

Inactive Ingredients

corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate,  povidone, titanium dioxide.

Questions or comments?

Principal Display Panel

*Compare to the active ingredient in Zyrtec®

Cetirizine HCL Tablets, USP 10 mg

Antihistamine

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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Cetirizine HCL Tablets

INGREDIENTS AND APPEARANCE

INDOOR OUTDOOR ALLERGIES 
cetirizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63548-0739
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)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	432
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63548-0739-3	1 in 1 BOX	07/01/2019
1		300 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
ANDA	ANDA077946	07/01/2019

Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)