Childrens Cough Mucus Relief

Manufacturer
Discount Drug Mart | AptaPharma Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:57

Label at a glance#

ProductChildrens Cough Mucus Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections

Indications and uses

temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Dosage and administration

do not take more than 6 doses in any 24-hour period age                                                                   dose Children 6 years to 12 years                               1 to 2 teaspoonfuls (tsps) every 4 hours Children 4 years to under 6 years                        1/2 to 1 teaspoonful (tsps) every 4 hours Children under 4 years                                         do not use

Label contents#

Full prescribing information#

Drug FactsActive ingredients(in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Warnings

WARNINGS SECTION

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistant  headache.

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period

age                                                                   dose

Children 6 years to 12 years                               1 to 2 teaspoonfuls (tsps) every 4 hours
Children 4 years to under 6 years                        1/2 to 1 teaspoonful (tsps) every 4 hours
Children under 4 years                                         do not use

Other information

OTHER SAFETY INFORMATION

  • each teaspoonful contains sodium 3 mg
  • store between20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
  • Keep carton for full direction for use

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Children's Cough Mucus Relief product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug
mart
FOOD FAIR

DO NOT USE IF PRINTED SEAL, UNDER CAP IS TORN OR MISSING

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*

Children's Cough Mucus Relief

Cough Suppressent

Expectorant

Dextromethorphan HBr 5 mg

Guaifensin 100 mg

Relieves Chest Congestion

Thins & Loosens Mucus

Alcohol free
for ages 4 to 12

CHERRY FLAVOR

4 FL OX (118 ml)

* this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributer of Childrens Mucinex® Cough.

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

BX-052

AptaPharmDD Child CoughMucusAptaPharmDD Child CoughMucus

AptaPharmDD Child CoughMucus 1AptaPharmDD Child CoughMucus 1

res

AptaPharmDD Child CoughMucusAptaPharmDD Child CoughMucus

AptaPharmDD Child CoughMucus 1AptaPharmDD Child CoughMucus 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN2
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY2
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-512-24Childrens Cough Mucus Relief118 mL in 1 BOTTLELIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-512CHILDRENS COUGH MUCUS RELIEF (DEXTROMETHORPHANN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]2Current NDC, Legacy NDC, 1 package rows20231230_2c27aca4-e1e2-419a-84c4-857718ca49da.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53943-51253943-512-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

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
Childrens Cough Mucus ReliefDEXTROMETHORPHANN HBR, GUAIFENESINDiscount Drug Mart2c27aca4-e1e2-419a-84c4-857718ca49da2023-12-29WarningsExact identifier
ndc (package): 53943-512-24
ndc (product): 53943-512
ndc11 (package): 53943051224
spl id: 5b5266a3-3ff0-450b-8427-b59b1007e3c7
spl set id: 2c27aca4-e1e2-419a-84c4-857718ca49da

Reported adverse events (FAERS/openFDA)#

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