FDA.reportPublic FDA data

Chlorpheniramine Maleate 4 mg

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2023-03-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:36

Label at a glance#

ProductChlorpheniramine Maleate 4 mg
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure16 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes

Dosage and administration

adults and children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours children 6 years to under 12 years take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours children under 6 years do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

GENERAL PRECAUTIONS SECTION

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Drug Facts continued on back of label

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and overtake 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 yearstake 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours
children under 6 yearsdo not use

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calsium 40 mg
  • store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

* Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton®

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-022-01

Chlorpheniramine Maleate 4mg

ANTIHISTAMINE

100 Tablets

*Compare to Active Ingredients in Chlor-Trimeton®

Chlorpheniramine Maleate 4 mgChlorpheniramine Maleate 4 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN4
1363309chlorpheniramine maleate 4 MG Oral TabletSCD4

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
69618-022-012025-01-30C16284748780-1f386c649-ee66-0266-e053-dadaa90a7c1aChlorpheniramine Maleate 4 mg
69618-022-102025-01-30C16284748780-1f386c649-ee66-0266-e053-dadaa90a7c1aChlorpheniramine Maleate 4 mg
69618-022-012023-03-29C16284748780-1f386c649-ee66-0266-e053-dadaa90a7c1aChlorpheniramine Maleate 4 mg
69618-022-102023-03-29C16284748780-1f386c649-ee66-0266-e053-dadaa90a7c1aChlorpheniramine Maleate 4 mg
69618-022-012023-01-30C16284748780-1f386c649-ee66-0266-e053-dadaa90a7c1aChlorpheniramine Maleate 4 mg
69618-022-102023-01-30C16284748780-1f386c649-ee66-0266-e053-dadaa90a7c1aChlorpheniramine Maleate 4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-022-01Chlorpheniramine Maleate 4 mg100 in 1 BOTTLE, PLASTICTABLET1004
69618-022-10Chlorpheniramine Maleate 4 mg1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-022CHLORPHENIRAMINE MALEATE 4 MG (CHLORPHENIRAMINE MALEATE) TABLET [RELIABLE 1 LABORATORIES LLC]4Legacy NDC, 2 package rows20230331_31dec627-f2e4-6dbe-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-022-01EA - Each69618-022017f0907-2077-456a-87c8-d7856c70beb512016-05-16
69618-022-10EA - Each69618-0227b7e8781-2215-47be-92d1-6ac20cc04e1812016-05-16

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-02269618-022-01, 69618-022-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
f811e228-e47f-e4b4-e053-6394a90a3a0d31dec627-f2e4-6dbe-e054-00144ff8d46c2023-03-29WarningsExact identifier
spl id: f811e228-e47f-e4b4-e053-6394a90a3a0d
spl set id: 31dec627-f2e4-6dbe-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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