FDA.reportPublic FDA data

Good Sense Allergy Relief

Manufacturer
L. Perrigo Company
Effective date
2016-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:30

Label at a glance#

ProductGood Sense Allergy Relief
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure9 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 4 to under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use

Storage and handling

• store at 20-25 ° C (68-77 ° 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 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

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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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

  • 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

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, 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 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 Hour

Chlorpheniramine Maleate 4 mg

Antihistamine

Allergy Relief

Tablets

Actual Size

Sneezing

Itchy, WateryEyes

RunnyNose

ItchyThroat

Compare to active ingredient of Chlor-Trimeton® Tablets

24 Tablets

Good Sense Allergy Relief image
Good Sense Allergy Relief image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0042-62EA - Each0113-004238dc13c2-3e68-4ccb-9b84-15539a8de3dd12024-06-10
0113-0042-78EA - Each0113-0042dfda3b4c-5e84-40a3-b064-0db6cb12b23212018-07-03

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0113-00420113-0042-62, 0113-0042-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT

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
bea5e377-0685-4771-b9bc-fe2352b1b0c5cffbc4ec-9d38-484c-8e1f-a49e6f88dd922021-07-12WarningsExact identifier
spl set id: cffbc4ec-9d38-484c-8e1f-a49e6f88dd92

Reported adverse events (FAERS/openFDA)#

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