Childrens Mucus Relief Cough Cherry

Manufacturer
P & L Development, LLC
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:55:55

Label at a glance#

ProductChildrens Mucus Relief Cough Cherry
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure12 sections

Indications and uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help your child get to sleep

Dosage and administration

• do not exceed 6 doses in a 24-hour period age                                                                dose children 6 years to under 12 years           1-2 teaspoonfuls (tsps)every 4 hours children 4 years to under 6 years             1/2-1 teaspoonful (tsp)every 4 hours children under 4 years                               do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg

Purposes

OTC - PURPOSE SECTION

Dextromethorphan HBr, USP...............Cough suppressant
Guaifenesin, USP...................................Expectorant

Uses

INDICATIONS & USAGE SECTION

• helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of
bothersome mucus and make coughs more
productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation
as may occur with the common cold or inhaled
irritants
• the intensity of coughing
• the impulse to cough to help your child get to
sleep

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 the child has

OTC - ASK DOCTOR SECTION

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with
asthma or chronic bronchitis

Stop use and ask a doctor if

OTC - STOP USE SECTION

• new symptoms occur
• redness or swelling is present
• fever gets worse or lasts more than 3 days
• pain or cough gets worse or lasts more than
5 days (children)
• cough comes back or occurs with fever, rash, or
headache that lasts. These could be signs
of a serious illness.

When using this product

OTC - WHEN USING SECTION

• do not use more than directed

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed 6 doses in a 24-hour period

age                                                                dose
children 6 years to under 12 years           1-2 teaspoonfuls (tsps)every 4 hours
children 4 years to under 6 years             1/2-1 teaspoonful (tsp)every 4 hours
children under 4 years                               do not use

Other Information

SPL UNCLASSIFIED SECTION

• each teaspoon contains: sodium 3 mg
• store at controlled room temperature
• dosage cup provided

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous,
dextrose, flavors, glycerin, methyl paraben, potassium
sorbate, propylene glycol, propyl paraben,
purified water, red 33, red 40, saccharin sodium,
sodium hydroxide, sucralose, xanthan gum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aaron Brands

Children's

Mucus Relief

Cough

Cherry Flavor

4 FL OZ (118 mL)

image of label
image of label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W21
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK6021
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49580-330449580-3304-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 12 · 688 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISHAMPOO / TOPICAL3 mgExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY, METERED / NASAL1.2 mg/1mlExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, CHEWABLE / ORAL0.14 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / OPHTHALMIC0.09 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUM ANHYDROUSSACCHARIN SODIUM ANHYDROUSI4807BK602TABLET / ORAL97 mgExact identifier — unii candidate
17 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
122194e9-2524-4f1a-be2a-326b0805d1d7e6d78e2b-6267-4347-9e96-4c03c951fa562019-12-04WarningsExact identifier
spl id: 122194e9-2524-4f1a-be2a-326b0805d1d7
spl set id: e6d78e2b-6267-4347-9e96-4c03c951fa56

Reported adverse events (FAERS/openFDA)#

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