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NDC 51672-2121-04 Childrens Fexofenadine Hydrochloride 30 mg/5mL Details
Childrens Fexofenadine Hydrochloride 30 mg/5mL
Childrens Fexofenadine Hydrochloride is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. The primary component is FEXOFENADINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash in adults and children 6 months of age and older. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.
Related Packages: 51672-2121-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine
Product Information
| NDC | 51672-2121 |
|---|---|
| Product ID | 51672-2121_d43ceeee-a210-45ca-a204-57c465c4e15c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Childrens Fexofenadine Hydrochloride |
| Proprietary Name Suffix | HIVES |
| Non-Proprietary Name | Fexofenadine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/5mL |
| Substance Name | FEXOFENADINE HYDROCHLORIDE |
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208123 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 51672-2121-04 (51672212104)
| NDC Package Code | 51672-2121-4 |
|---|---|
| Billing NDC | 51672212104 |
| Package | 1 BOTTLE in 1 CARTON (51672-2121-4) / 60 mL in 1 BOTTLE |
| Marketing Start Date | 2017-11-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c9bd7c29-a462-43ff-9cb9-453ffa9b46ba Details
Uses
Warnings
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
- drooling
- 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:
- foods
- insect stings
- medicines
- 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)
Directions
- 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
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to the active
ingredient in Children's
Allegra® Hives*
NDC 51672-2121-8
Children's
Fexofenadine HCI
Oral Suspension,
30 mg/ 5 mL
Antihistamine
HIVES
NON-DROWSY
Berry Flavor
Ages 6 Years
& Older
12
Hour
RELIEF OF
ITCHING DUE
TO HIVES
Dye free / Alcohol free / Sugar free
LIQUID
Oral Suspension
4 fl. oz.
(120 mL)
INGREDIENTS AND APPEARANCE
| CHILDRENS FEXOFENADINE HYDROCHLORIDE
HIVES
fexofenadine hydrochloride suspension |
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| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |