FDA.reportPublic FDA data

Chlorpheniramine Maleate 4mg

Manufacturer
Strive Pharmaceuticals Inc
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:33:43

Label at a glance#

ProductChlorpheniramine Maleate 4mg
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 4mg

INACTIVE INGREDIENT SECTION

D&C yellow #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch

DOSAGE & ADMINISTRATION SECTION

  • take with a full glass of water
  • do not take more than directed
adults and children 12 yers of age and over1 tablet every 4 to 6 hours, do not take more than 6 tablets in 24 hours
children 6 to under 12 years of age1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
children under 6 years of age ask a doctor

INDICATIONS & USAGE SECTION

temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS SECTION

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostrate gland

Ask a doctor or a pharmacist before use if

you sre taking sedatives or tranquilzers

When using this product

  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating a machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION

Antihistamine

OTHER SAFETY INFORMATION

  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • protect from excessive heat and moisture

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CT11341CT11341

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN2
1363309chlorpheniramine maleate 4 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-113-412022-01-28C16284748780-1d6a99b39-e5dd-a426-e053-dadaa90af4c2Allergy - Alergia (Chlorpheniramine Maleate 4mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-113-41Chlorpheniramine Maleate 4mg4 in 1 PACKAGETABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-113CHLORPHENIRAMINE MALEATE 4MG TABLET [STRIVE PHARMACEUTICALS INC]2Legacy NDC, 1 package rows20201117_91d2ec38-7ea2-2b3a-e053-2a95a90af3fd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-11370692-113-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b43d643e-eb36-b295-e053-2995a90a7b6f91d2ec38-7ea2-2b3a-e053-2a95a90af3fd2020-11-16WarningsExact identifier
spl id: b43d643e-eb36-b295-e053-2995a90a7b6f
spl set id: 91d2ec38-7ea2-2b3a-e053-2a95a90af3fd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.