DAYCLEAR ALLERGY RELIEF CHEWABLES- chlophedianol hydrochloride, pyrilamine maleate tablet, chewable

DAYCLEAR ALLERGY RELIEF CHEWABLES by

Drug Labeling and Warnings

DAYCLEAR ALLERGY RELIEF CHEWABLES by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DayClear Allergy Relief Chewable

Drug Facts

Active ingredients (in each tablet)

Chlophedianol HCl 25 mg

Pyrilamine Maleate 25 mg

Purpose

Cough Suppressant

Antihistamine

Uses

■ temporarily relieves these symptoms

due to the common cold, hay fever, or other upper respiratory allergies:

■ itchy nose or throat   ■ sneezing   

■ itchy, watery eyes   ■ runny nose

■ cough due to minor throat and

bronchial irritation

Warnings

Ask a doctor before use if you have

■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

■ cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use

if you are taking sedative or tranquilizers

When using this product

■ do not use more than directed

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occurs

■ symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition

■ new symptoms occur

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

■ do not exceed 4 doses per 24-hour period

■ adults and children 12 years and older: chew 1 tablet every 6 to 8 hours

■ children under 12 years:       do not use

Other information

■ read all product information before using

■ store at room temperature 20-30°C (68-86°F)

Inactive ingredients

crospovidone, flavor, L-menthol, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, stevia, sucralose

Questions or comments?

Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

PRINCIPAL DISPLAY PANEL

NDC: 58809-222-24
DayClear
Allergy
Relief
Chewables
24 Chewable Tablets

INGREDIENTS AND APPEARANCE

DAYCLEAR ALLERGY RELIEF CHEWABLES 
chlophedianol hydrochloride, pyrilamine maleate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-222
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 2S7830E561)
LEVOMENTHOL (UNII: BZ1R15MTK7)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor	MINT	Imprint Code	DC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-222-24	1 in 1 CARTON	01/02/2020
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/02/2020

Labeler - GM Pharmaceuticals, INC (793000860)