Label: CHILDRENS ALLERGY RELIEF- fexofenadine hcl tablet
- NDC Code(s): 63548-0662-5
- Packager: PLD Acquisitions LLC DBA Avéma Pharma Solutions
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 13, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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)
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Directions
adults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
*Compare to the active ingredient in Children's Allegra® Allergy 12 Hour
Children's Allergy Relief
Fexofenadine HCL USP 30 mg
Antihistamine
24 Hour Relief of:
- sneezing
- runny nose
- itchy, watery eyes
- itchy nose or throat
Indoor and outdoor allergy relief
Non-drowsy
Tablets
*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 12 hour.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
- Product Label
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-0662 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 Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LIGHT MINERAL OIL (UNII: N6K5787QVP) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score no score Shape CAPSULE Size 6mm Flavor Imprint Code J;42 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63548-0662-5 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204097 10/01/2019 Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)