Childrens Cough Relief

Manufacturer: QUALITY CHOICE (Chain Drug Marketing Association)
Effective date: 2018-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:39:22

Label at a glance#

ProductChildrens Cough Relief

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE

Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impluse to cough to help you get to sleep

Dosage and administration

take recommended dosage or as directed by a doctor measure only with dosing cup provided Do not use any other dosing device. keep dosing cup with product mL = milliliter shake well before using age dose adults and children 12 years and over 10 mL every 6-8 hours not to exceed 4 doses in 24 hours children 6 to 11 years of age 5 mL every 6-8 hours not to exceed 4 doses in 24 hours children under 6 years of age...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact248-449-9300

Websitewww.qualitychoice.com

www.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 15 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the impluse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

cough that occurs with too much phlegm (mucus)
chronic cough that lasts as occurs with smoking, asthma or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

When using this product,

OTC - WHEN USING SECTION

do not use more than directed

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take recommended dosage or as directed by a doctor
measure only with dosing cup provided Do not use any other dosing device.
keep dosing cup with product
mL = milliliter
shake well before using

age	dose
adults and children 12 years and over	10 mL every 6-8 hours not to exceed 4 doses in 24 hours
children 6 to 11 years of age	5 mL every 6-8 hours not to exceed 4 doses in 24 hours
children under 6 years of age	do not use

Other information

SPL UNCLASSIFIED SECTION

each 5 mL contains: sodium 2 mg
store at 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red #33, disodium EDTA, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's Cough Relief

Cough Suppressant

Dextromethorphan HBr 15 mg

Cough Suppressant

For Ages 6 & Over

6-8 Hour Relief

Alcohol Free

Grape Flavor

FL OZ (mL)

Contains no fever reducer or pain reliever.

See side panel for full dosing directions.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice Childrens Cough Relief Grape

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-070-04	ML - Milliliter	63868-070	25ef1027-24fb-4668-92ad-4bf4f01ca1f7	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	3
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	INACTIVE INGREDIENT	ZYD53NBL45	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Childrens Cough Relief
Dextromethorphan HBr
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
FD&C BLUE NO. 1
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
PROPYLENE GLYCOL
WATER
D&C RED NO. 33
SODIUM BENZOATE
SUCRALOSE
SUCROSE
XANTHAN GUM
POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-070	63868-070-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	ZYD53NBL45	IACT
GLYCERIN	PDC6A3C0OX	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 489 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE / ORAL		131 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION, CONCENTRATE / INTRAVENOUS		60 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SYRUP / ORAL		1 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOTION / TOPICAL		211 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d2682efe-53c2-4ef6-b39c-317344301002			905f27f6-aa64-45f9-bdca-347a7c5af9d1	2018-12-26	Warnings	Exact identifier spl id: d2682efe-53c2-4ef6-b39c-317344301002 spl set id: 905f27f6-aa64-45f9-bdca-347a7c5af9d1

Reported adverse events (FAERS/openFDA)#

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