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good sense childrens allergy relief

Perrigo Children’s Allergy Relief Drug Facts

Approved
Approval ID

4ce244e2-9fbc-4371-8806-789fd3a61a09

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 6, 2025

Manufacturers
FDA

L. Perrigo Company

DUNS: 006013346

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 Code0113-1719
Application NumberANDA075728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2025
FDA Product Classification

INGREDIENTS (11)

LORATADINEActive
Quantity: 5 mg in 5 mL
Code: 7AJO3BO7QN
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

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good sense childrens allergy relief - FDA Drug Approval Details