Only For

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2019-05-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:33

Label at a glance#

ProductOnly For ALLERGY
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure10 sections

Indications and uses

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

Dosage and administration

take with a full glass of water Do not take more than directed  adults and children 12 years of age 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 of age  ½ 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

Storage and handling

Store at room temperature between 20-25°C (68-77°F). protect from excessive heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 4mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

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:

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 prostate gland

Do not take if
you are taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Do not use to make a child sleepy

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • take with a full glass of water
  • Do not take more than directed
 adults and children 12 years of age 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 of age ½ 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

Other Information:

STORAGE AND HANDLING SECTION

  • Store at room temperature between 20-25°C (68-77°F).
  • protect from excessive heat and moisture

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS ?

OTC - QUESTIONS SECTION

1-833-665-9444.

SPL UNCLASSIFIED SECTION

NDC: 73006-113-41

ANTIHISTAMINE

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
73006-113-412022-01-28C16284748780-1d6a99b39-d1e2-a426-e053-dadaa90af4c2Only For - ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-113-41Only ForALLERGY1 in 1 CARTONTABLET12
73006-113-41Only ForALLERGY4 in 1 BLISTER PACKTABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-113ONLY FOR ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [O4 GLOBAL TRADING USA, LLC ]2Legacy NDC, 2 package rows20190529_796150ee-d59b-4af2-ad10-d82c083807ea.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73006-11373006-113-41

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
50f3aea0-dbb8-413c-9d44-b4a0c8205808796150ee-d59b-4af2-ad10-d82c083807ea2019-05-28WarningsExact identifier
spl id: 50f3aea0-dbb8-413c-9d44-b4a0c8205808
spl set id: 796150ee-d59b-4af2-ad10-d82c083807ea

Reported adverse events (FAERS/openFDA)#

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