Cough Relief Grape

Manufacturer
Western Family Foods, Inc.
Effective date
2018-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:38:53

Label at a glance#

ProductCough Relief Grape Cough Suppressant
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 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 impulse 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 shake well before using mL = milliliter 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 ag...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 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 impulse 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 the 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
  • shake well before using
  • mL = milliliter

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, edetate disodium, FD&C blue #1 flavor, glycerin hydroxyethyl cellulose, high fructose corn syrup, polyethylene glycol propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DEXTROMETHORPHAN HBr 15 mg

Cough Suppressant

COUGH RELIEF

Ages 6 & Over

Grape Flavor

Alcohol-Free

6-8 Hour Relief

FL OZ (mL)

Dosing Cup Included

Cough Suppressant

CONTAINS NO FEVER REDUCER OR PAIN RELIEVER

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

Proudly Distributed by Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Western Family Cough Relief GrapeWestern Family Cough Relief Grape 

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)INACTIVE INGREDIENTL605B5892V1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55312-03855312-038-04

Ingredients#

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

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

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 · 482 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d46a2a7d-0aa2-41b3-b47e-93a9dbc137695694b1a1-95ba-4dd4-9d97-4f9ded1d66172018-12-27WarningsExact identifier
spl id: d46a2a7d-0aa2-41b3-b47e-93a9dbc13769
spl set id: 5694b1a1-95ba-4dd4-9d97-4f9ded1d6617

Reported adverse events (FAERS/openFDA)#

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