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NDC 58809-0222-24 DAYCLEAR ALLERGY RELIEF CHEWABLES 25; 25 mg/1; mg/1 Details

DAYCLEAR ALLERGY RELIEF CHEWABLES 25; 25 mg/1; mg/1

DAYCLEAR ALLERGY RELIEF 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	58809-0222
Product ID	58809-222_d5907515-133d-20e6-e053-2995a90ad7f3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DAYCLEAR ALLERGY RELIEF 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	25; 25
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 58809-0222-24 (58809022224)

Pricing Information	N/A
NDC Package Code	58809-222-24
Billing NDC	58809022224
Package	1 BOTTLE in 1 CARTON (58809-222-24) / 24 TABLET, CHEWABLE in 1 BOTTLE
Marketing Start Date	2020-01-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4c600c0a-4254-4fe6-8c4c-99095c5412f2 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	25 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:58809-222-24	1 in 1 CARTON	01/02/2020
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 1/2022

Document Id: d5907515-133d-20e6-e053-2995a90ad7f3

Set id: 4c600c0a-4254-4fe6-8c4c-99095c5412f2

Version: 2

Effective Time: 20220114