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NDC 61269-0527-94 Childrens Allergy 30 mg/5mL Details
Childrens Allergy 30 mg/5mL
Childrens Allergy is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by H2-Pharma, LLC. 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: 61269-0527-94Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine
Product Information
| NDC | 61269-0527 |
|---|---|
| Product ID | 61269-527_53bebdb2-1a62-40b9-8cd3-407cc2a70037 |
| Associated GPIs | |
| GCN Sequence Number | 061995 |
| GCN Sequence Number Description | fexofenadine HCl ORAL SUSP 30 MG/5 ML ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 97779 |
| HICL Sequence Number | 011595 |
| HICL Sequence Number Description | FEXOFENADINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Childrens Allergy |
| Proprietary Name Suffix | n/a |
| 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 | H2-Pharma, LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203330 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 61269-0527-94 (61269052794)
| NDC Package Code | 61269-527-94 |
|---|---|
| Billing NDC | 61269052794 |
| Package | 1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2022-07-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 84988f6d-85b1-45dd-89be-0333acc6b180 Details
Uses
Warnings
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
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 2 to under 12 years of age | take 5 mL every 12 hours; do not take more than 10 mL in 24 hours |
| children under 2 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 - 237 mL Bottle Carton
NDC 61269-527-98
*Compare to the active ingredient
in Children's Allegra® Allergy
Children's
Allergy
Fexofenadine HCl
Oral Suspension 30 mg/5 mL
Antihistamine
Indoor/Outdoor allergy relief
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat
12 Hour Relief
Ages 2 years and older
Non-drowsy
Dye-free
Alcohol-free
Use only with
enclosed dosing cup.
Wash and let air dry
after each use.
BERRY FLAVOR
8 fl oz (237 mL)
H2 pharma
INGREDIENTS AND APPEARANCE
| CHILDRENS ALLERGY
fexofenadine hydrochloride suspension |
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| Labeler - H2-Pharma, LLC (028473634) |