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childrens allergy relief

Meijer Distribution, Inc. Children’s Allergy Relief Drug Facts

Approved
Approval ID

b27f0bd0-4e61-4498-b5b7-54ae31f637f3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Meijer Distribution Inc

DUNS: 006959555

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

loratadine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-629
Application NumberANDA210033
Product Classification
M
Marketing Category
C73584
G
Generic Name
loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (10)

LORATADINEActive
Quantity: 5 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT

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childrens allergy relief - FDA Drug Approval Details