FDA.reportPublic FDA data

Pharbechlor

Manufacturer
Ulai Health LLC
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:19

Label at a glance#

ProductPharbechlor
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and over          1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours. children 6 to under 12 years  1/2 tablet (break tablet in half) every 4 to 6 hours. Do not to exceed 3 whole tablets in 24 hours. children under 6 years  ask a doctor

Storage and handling

store at 20-25 o C (68-77 o F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these following symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Do not use

OTC - DO NOT USE SECTION

to make a child sleepy.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over         1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours.
children 6 to under 12 years 1/2 tablet (break tablet in half) every 4 to 6 hours. Do not to exceed 3 whole tablets in 24 hours.
children under 6 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25 oC (68-77 oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, D&C yellow # 10, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-346-11

Manufactured in the USA

4 Hour Allergy Relief

*Compare to the active ingredient in Chlor-Trimeton ®

Pharbechlor

CHLORPHENIRAMINE MALEATE 4 MG - ANTIHISTAMINE

For Temporary relief of:

•Itchy,Watery Eyes  •Runny Nose

•Itchy Throat          •Sneezing

1000 Tablets

Ulai Pharbechlor 4 mg Tablet 1000 ct. LabelUlai Pharbechlor 4 mg Tablet 1000 ct. Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN3
1363309chlorpheniramine maleate 4 MG Oral TabletSCD3

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
73057-346-112022-01-31C16284748780-1d6a99b39-361d-a426-e053-dadaa90af4c2Drug Facts
73057-346-112022-01-28C16284748780-1d6a99b39-361d-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-346-11Pharbechlor1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-346PHARBECHLOR (CHLORPHENIRAMINE MALEATE 4MG) TABLET [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 1 package rows20250122_6a1a5cef-e946-4ba8-9402-557c6adf45f9.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73057-34673057-346-11

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

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
PharbechlorCHLORPHENIRAMINE MALEATE 4MGUlai Health LLC6a1a5cef-e946-4ba8-9402-557c6adf45f92025-01-20WarningsExact identifier
ndc (package): 73057-346-11
ndc (product): 73057-346
ndc11 (package): 73057034611
spl id: 2c27a450-3731-df6a-e063-6394a90a7740
spl set id: 6a1a5cef-e946-4ba8-9402-557c6adf45f9

Reported adverse events (FAERS/openFDA)#

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