FDA.reportPublic FDA data

Allergy Relief

Manufacturer
STRATEGIC SOURCING SERVICES LLC
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:27:55

Label at a glance#

ProductAllergy Relief
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure8 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

adults and children 12 years and over 1 tablet every 4 to 6 hours, not to exceed 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 20°-25°C (68°-77°F) in a dry place retain carton for complete product information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each tablet)Purpose
Chlorpheniramine maleate 4 mgAntihistamine

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
children 6 to under 12 years of age½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
children under 6 years of ageask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HealthMart(R)

NDC 62011-0441-1

Compare to Chlor-Trimeton(R) Allergy 4-Hour active ingredient

4 HOUR

Allergy Relief

Chlorpheniramine Maleate 4 mg

Antihistamine

For Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

ACTUAL SIZE

24 TABLETS

image descriptionimage description

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
62011-044162011-0441-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ALUMINUM OXIDELMI26O6933IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB

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
ee9d07f9-faf7-f0bb-e053-2a95a90a6c687a22d1f5-72b0-4cce-ae7b-2c1a79725b1f2022-11-29WarningsExact identifier
spl set id: 7a22d1f5-72b0-4cce-ae7b-2c1a79725b1f

Reported adverse events (FAERS/openFDA)#

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