Chlorpheniramine Maleate

Manufacturer
Rugby Laboratories Inc. | Advance Pharmaceutical Inc.
Effective date
2012-12-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:44:04

Label at a glance#

ProductChlorpheniramine Maleate
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

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

Dosage and administration

take every 4-6 hours do not take more than 6 doses in 24 hours Adults & children 12 years and over 1 tablet Children 6 to under 12 years ½ tablet Children under 6 years do not use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Chlorpheniramine Maleate 4 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have

  • 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 taking sedatives or tranquilizers

When using this product

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

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

    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

  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
    Adults & children 12 years and over 1 tablet
    Children 6 to under 12 years½ tablet
    Children under 6 yearsdo not use

Other Information

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • each tablet contains: calcium 40 mg
  • store between 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 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

* Rugby Laboratories, Inc. is not affiliated with the owner of the trademark Chlor-Trimeton®. Aller·chlor® is distributed by Rugby Laboratories, Inc.

Rugby® Duluth, Georgia 30097

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • C:\Users\advance\Desktop\word docs - rugby\Chlorpheniramine 4mg-24ct\figure1.pngC:\Users\advance\Desktop\word docs - rugby\Chlorpheniramine 4mg-24ct\figure1.png

NDC 0536-3467-35

Rugby

Aller·chlor®

Chlorpheniramine Maleate 4 mg Tablets
Antihistamine

24 Tablets

  • C:\Users\advance\Desktop\word docs - rugby\Chlorpheniramine 4mg-24ct\Figure 2.pngC:\Users\advance\Desktop\word docs - rugby\Chlorpheniramine 4mg-24ct\Figure 2.png

0536-3467-01

Rugby

Aller·Chlor®

Chlorpheniramine Maleate 4 mg
Antihistamine

100 Tablets

C:\Users\advance\Desktop\word docs - rugby\Chlorpheniramine 4mg-24ct\Figure 3.pngC:\Users\advance\Desktop\word docs - rugby\Chlorpheniramine 4mg-24ct\Figure 3.png

0536-3467-10

Rugby

Aller·Chlor®

Chlorpheniramine Maleate 4 mg
Antihistamine

1000 Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3467-01EA - Each0536-34679a67beb2-9f86-4e28-a570-17fd770de74b12013-02-13
0536-3467-10EA - Each0536-346734cca9c3-e50f-488b-9090-acdec438bddc12013-02-13
0536-3467-35EA - Each0536-34671fa453e4-4299-4e44-9564-5ac11d3c30c012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z3
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92J3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH483
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ3

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
0536-34670536-3467-35, 0536-3467-01, 0536-3467-10

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 206 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, CHEWABLE / ORAL50 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FOR SUSPENSION / ORAL406 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSHAMPOO / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii candidate
22 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE PELLETS / ORAL127 mgExact identifier — unii candidate
22 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TROCHE / ORAL50 mgExact identifier — unii candidate
22 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii candidate
31 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE / ORAL20 mgExact identifier — unii candidate
31 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCREAM / TOPICAL36 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
31 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
31 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii candidate
31 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATEANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JPOWDER / SUBLINGUAL30 mgExact identifier — unii candidate
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48SUSPENSION / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSOAP / TOPICAL1.4 %w/wExact identifier — unii candidate
31 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / ORAL2 mgExact identifier — unii candidate
31 equally ranked IID candidates

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
e7a2920e-33a7-4c97-b26f-a985bef7106bdb3b283d-1319-4aaa-a1a9-1eb86efb53942019-12-18WarningsExact identifier
spl set id: db3b283d-1319-4aaa-a1a9-1eb86efb5394

Reported adverse events (FAERS/openFDA)#

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