H-E-B Allergy Relief: Package Insert and Label Information

H-E-B ALLERGY RELIEF- cetirizine hydrochloride solution
H E B

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 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 right away (1-800-222-1222).

Directions

  • use only with enclosed dosing cup
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose

Questions?

Call 1-866-923-4914

DISTRIBUTED BY H-E-B, SAN ANTONIO, TX 78204

PRINCIPAL DISPLAY PANEL — 120 mL Bottle Carton

Compare to Children’s Zyrtec®
active ingredient*

H-E-B ®

ALLERGY RELIEF

Children’s

Cetirizine Hydrochloride
Oral Solution
1 mg/mL (Antihistamine)

24 Hour Indoor & Outdoor Allergies

For Ages 2 & Over

  • Relieves:
    Sneezing/Runny Nose
    Itchy, Watery Eyes
    Itchy Throat or Nose
  • Dosing Cup
    Enclosed

Grape Syrup

4 FL OZ (120 mL)

Principal Display Panel -- 120 mL Bottle Carton
(click image for full-size original)
H-E-B ALLERGY RELIEF
cetirizine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
acetic acid
glycerin
methylparaben
propylene glycol
propylparaben
water
sodium acetate
sucrose
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-208-88 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 mL in 1 BOTTLE This package is contained within the CARTON (37808-208-88)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090182 04/22/2008
Labeler — H E B (007924756)
Registrant — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE (37808-208)

Revised: 12/2012 H E B

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