CHILDRENS DAYCLEAR ALLERGY COUGH CHEWABLES- chlophedianol hydrochloride, pyrilamine maleate tablet, chewable

Childrens DayClear Allergy Cough Chewables by

Drug Labeling and Warnings

Childrens DayClear Allergy Cough 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

Drug Facts

Active ingredients

 (in each tablet)

Chlophedianol HCl 12.5 mg

Pyrilamine Maleate 12.5 mg

Purpose

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 sedatives 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

■ cough persists for more than 1 week, tends to recur, or is 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 more than 4 doses per 24-hour period

adults and children 12 years and older:        chew 2 tablets every 6 to 8 hours

children 6 to under 12 years of age:             chew 1 tablet every 6 to 8 hours

children under 6 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

Children’s
DayClear
Allergy
Cough
Chewables
Cool Blast
24 Chewable Tablets

INGREDIENTS AND APPEARANCE

CHILDRENS DAYCLEAR ALLERGY COUGH CHEWABLES 
chlophedianol hydrochloride, pyrilamine maleate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-223
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	12.5 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: 58809-223-24	1 in 1 CARTON	12/26/2019
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58809-223-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/26/2019

Labeler - GM Pharmaceuticals, INC (793000860)