FDA.reportPublic FDA data

DAYCLEAR ALLERGY RELIEF

Manufacturer
GM Pharmaceuticals, INC
Effective date
2023-11-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:20:03

Label at a glance#

ProductDAYCLEAR ALLERGY RELIEF
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy watery eyes cough due to minor throat and bronchial irritation

Dosage and administration

do not take more than 4 doses per 24-hours adults and children 12 years of age and over: 1 tablet every 6 to 8 hours children 6 to under 12 years: 1/2 tablet every 6 to 8 hours children under the age of 6: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DAYCLEAR- ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET

GM Pharmaceuticals, Inc.

DayClear Allergy Relief Tablet 30 count

Drug Facts

Active Ingredients (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlophedianol HCl 25 mg

Pyrilamine Maleate 50 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy watery eyes
  • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the 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
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • New symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health profession 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 4 doses per 24-hours
  • adults and children 12 years of age and over: 1 tablet every 6 to 8 hours
  • children 6 to under 12 years: 1/2 tablet every 6 to 8 hours
  • children under the age of 6: do not use

Other information

OTHER SAFETY INFORMATION

  • avoid excess heat and humidity
  • store at room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-535-0305

9 a.m. - 5 p.m. CST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-221-30
DAYCLEAR
ALLERGY
RELIEF
30 TABLETS

PRINCIPAL DISPLAY PANEL NDC 58809-221-30 DAYCLEAR ALLERGY RELIEF 30 TABLETSPRINCIPAL DISPLAY PANEL NDC 58809-221-30 DAYCLEAR ALLERGY RELIEF 30 TABLETS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-221-30EA - Each58809-221659f2910-d358-4d56-a618-2266710cd6c312018-10-11

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
58809-22158809-221-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB

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
0b2780ac-ab93-dadd-e063-6394a90a83ca4da2d858-6d7d-4afc-95f2-4a02b02281ff2023-11-27WarningsExact identifier
spl id: 0b2780ac-ab93-dadd-e063-6394a90a83ca
spl set id: 4da2d858-6d7d-4afc-95f2-4a02b02281ff

Reported adverse events (FAERS/openFDA)#

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