Label: CHILDRENS FEXOFENADINE HYDROCHLORIDE HIVES- fexofenadine hydrochloride suspension
- NDC Code(s): 51672-2121-1, 51672-2121-4, 51672-2121-8
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 29, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
Severe Allergy Warning
Get emergency help immediately if you have hives along with any of the following symptoms:
- swelling of tongue
- trouble swallowing
- swelling in or around mouth
- trouble speaking
- wheezing or problems breathing
- dizziness or loss of consciousness
These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
Do not use
- to prevent hives from any known cause such as:
- insect stings
- latex or rubber gloves
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- kidney disease. Your doctor should determine if you need a different dose.
- hives that are an unusual color, look bruised or blistered
- hives that do not itch
When using this product
- do not take more than directed
- do not take at the same time as aluminum or magnesium antacids
- do not take with fruit juices (see Directions)
Stop use and ask a doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve after 3 days of treatment
- the hives have lasted more than 6 weeks
- shake well before using
- use only with enclosed dosing cup
Note: mL = milliliters adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 6 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 6 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to the active
ingredient in Children's
30 mg/ 5 mL
Ages 6 Years
Dye free / Alcohol free / Sugar free
4 fl. oz.
INGREDIENTS AND APPEARANCE
CHILDRENS FEXOFENADINE HYDROCHLORIDE HIVES
fexofenadine hydrochloride suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (Fexofenadine - UNII:E6582LOH6V) Fexofenadine Hydrochloride 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength butylparaben (UNII: 3QPI1U3FV8) edetate disodium (UNII: 7FLD91C86K) maltitol (UNII: D65DG142WK) poloxamer 407 (UNII: TUF2IVW3M2) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B) sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN) sucralose (UNII: 96K6UQ3ZD4) titanium dioxide (UNII: 15FIX9V2JP) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2121-4 1 in 1 CARTON 11/09/2017 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51672-2121-8 1 in 1 CARTON 11/09/2017 2 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:51672-2121-1 1 in 1 CARTON 11/09/2017 3 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208123 11/09/2017 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)