FDA.reportPublic FDA data

Creomulsion For Children Soothing Cough Syrup Drug Facts

Manufacturer
Socius Care, LLC
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:46:03

Label at a glance#

ProductCreomulsion For Children
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections

Indications and uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Dosage and administration

Do not take more than 6 doses in any 24 period. Use enclosed dose cup. Children 6 years to under 12 years 10mL (2tsp) every 4 hours Children 2 to under 6 years 5mL (1tsp) every 4 hours Children under 2 years Do not use

Storage and handling

store at 20-25°C (68-77°F) packaged with tamper evident seal around cap contains no alcohol

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 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 a cold.

Warnings

WARNINGS SECTION

Do not use if you are now taking 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 a pharmacist before taking the product.

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have cough that occurs with too much phlegm (mucus)
  • have cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

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 period. Use enclosed dose cup.
Children 6 years to under 12 years10mL (2tsp) every 4 hours
Children 2 to under 6 years5mL (1tsp) every 4 hours
Children under 2 yearsDo not use

Other Information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • packaged with tamper evident seal around cap
  • contains no alcohol

Inactive Ingredients

INACTIVE INGREDIENT SECTION

caramel, citric acid, corn syrup, FD and C Red No. 40, flavor, menthol, potassium sorbate, purified water, sodium benzoate, sucrose

Questions or Comments

OTC - QUESTIONS SECTION

Call 8am - 4pm Est. Mon - Fri. 1-404-566-8896

Money Back Guarantee

Guaranteed to give desired results or your money back.

Send carton top, reason for dissatisfaction, sales receipt, lot number, and your phone number to Socius Care, LLC

3939 Royal Dr. NW, Suite 230, Kennesaw, GA 30144

DESCRIPTION SECTION

How Creomulsion For Children Works?

Gentle Creomulsion For Children is specially formulated for a child's delicate system. It contains the most effective cough suppressant available without a prescription. It calms the urge to cough, while Creomulsion's smooth consistency soothes your child's throat.

Image of Carton and Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Creomulsion For Children CartonCreomulsion For Children CartonCreomulsion For Children Back LabelCreomulsion For Children Back Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1246254Creomulsion 5 MG in 5 mL Oral SolutionPSN10
1090946dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN10
1246254dextromethorphan hydrobromide 1 MG/ML Oral Solution [Creomulsion]SBD10
1090946dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD10
1246254Creomulsion 1 MG/ML Oral SolutionSY10
1246254Creomulsion 5 MG per 5 ML Oral SolutionSY10
1090946dextromethorphan HBr 20 MG in 20 mL Oral SolutionSY10
1090946dextromethorphan hydrobromide 5 MG per 5 ML Oral SolutionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70893-0012-0CreomulsionFor Children1 in 1 CARTONSYRUP110
70893-0012-1CreomulsionFor Children118 mL in 1 BOTTLESYRUP11810

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70893-001270893-0012-1, 70893-0012-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARAMELT9D99G2B1RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CORN SYRUP9G5L16BK6NIACT
FD&C RED NO. 40WZB9127XOAIACT
MENTHOLL7T10EIP3AIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCROSEC151H8M554IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-12-17monthly-update2026-06-03 17:46:13

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
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsExact identifier
ndc (package): 70893-0012-0
ndc (package): 70893-0012-1
ndc (product): 70893-0012
ndc11 (package): 70893001201
ndc11 (package): 70893001200
spl id: 4b0cac24-9068-3fda-e063-6394a90abd45
spl set id: 39d0e96c-1cc3-4961-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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