Search by Drug Name or NDC

NDC 58809-0223-24 Childrens DayClear Allergy Cough Chewables 12.5; 12.5 mg/1; mg/1 Details

Childrens DayClear Allergy Cough Chewables 12.5; 12.5 mg/1; mg/1

Childrens DayClear Allergy Cough Chewables is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by GM Pharmaceuticals, INC. The primary component is CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE.

Product Information

NDC	58809-0223
Product ID	58809-223_d5907e5f-7273-900e-e053-2a95a90a6616
Associated GPIs	43995702450510
GCN Sequence Number	080717
GCN Sequence Number Description	pyrilamine/chlophedianol TAB CHEW 12.5-12.5 ORAL
HIC3	B4E
HIC3 Description	NON-OPIOID ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB.
GCN	47677
HICL Sequence Number	040404
HICL Sequence Number Description	PYRILAMINE MALEATE/CHLOPHEDIANOL HCL
Brand/Generic	Brand
Proprietary Name	Childrens DayClear Allergy Cough Chewables
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLOPHEDIANOL HYDROCHLORIDE, Pyrilamine Maleate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	12.5; 12.5
Active Ingredient Units	mg/1; mg/1
Substance Name	CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Labeler Name	GM Pharmaceuticals, INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 58809-0223-24 (58809022324)

Pricing Information	N/A
NDC Package Code	58809-223-24
Billing NDC	58809022324
Package	1 BOTTLE in 1 CARTON (58809-223-24) / 24 TABLET, CHEWABLE in 1 BOTTLE
Marketing Start Date	2019-12-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a5a3e97-fca1-48a0-ae45-986411ae9294 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/26/2019

Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 1/2022

Document Id: d5907e5f-7273-900e-e053-2a95a90a6616

Set id: 4a5a3e97-fca1-48a0-ae45-986411ae9294

Version: 3

Effective Time: 20220114