CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR

Manufacturer
AptaPharma Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:44

Label at a glance#

ProductCHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg

OTC - PURPOSE SECTION

Purpose
Dextromelhorphan HBr, USP ....... Cough Suppressant
Guaifenestn,USP ........................Expectorant

INDICATIONS & USAGE SECTION

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 tube

WARNINGS SECTION

Warnings
Do not use ina 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
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma

When using this product•do not use more than directed

Stop use and ask a doctor if
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious condition.

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.

DOSAGE & ADMINISTRATION SECTION

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

                                  Age                                                                                            Dose

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

OTHER SAFETY INFORMATION

Other information• each teaspoon contains: sodium 3 mg

•store between 20-25°C (68-77°F) •do not refrigerate

•dosing cup provided • Keep carton for full direction for use

INACTIVE INGREDIENT SECTION

Inactive ingredients: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

OTC - QUESTIONS SECTION

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

CHILDREN'S MUCUS RELIEF COUGH CHERRY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AP SAFE                        NDC 76281-512-24

Children's                                        
Cough
Mucus Relief

Cough Suppressant
Expectorant

Cherry Flavor
4 FL OZ (118 mL)

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

*This product is not manufactured or distributed by
Reckitt Benckiser Inc., distributor of Children's
Mucinex®Cough.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

512 Cartn512 Cartn

512 Botl512 Botl

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130376281512243GTIN-13: 0376281512243
EAN-13: 0376281512243
GTIN-12: 376281512243
UPC-A: 376281512243
GTIN storage (14 digits): 00376281512243
512 Cartn.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76281-512-24CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR118 mL in 1 BOTTLELIQUID1184
76281-512-24CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR1 in 1 CARTONLIQUID14

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
76281-51276281-512-24

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

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 MUCUS RELIEF COUGH - CHERRY FLAVORDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAptaPharma Inc.9ae6fe74-80cd-482a-b3b9-3acafd6708ec2025-12-26WarningsExact identifier
ndc (package): 76281-512-24
ndc (product): 76281-512
ndc11 (package): 76281051224
spl id: 46e2eb82-2659-0e12-e063-6394a90acca3
spl set id: 9ae6fe74-80cd-482a-b3b9-3acafd6708ec

Reported adverse events (FAERS/openFDA)#

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