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Creomulsion for children - Medication Information

Product NDC Code 70893-0012
Drug Name

Creomulsion for children

Type Brand
Pharm Class Sigma-1 Agonist [EPC],
Sigma-1 Receptor Agonists [MoA],
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],
Uncompetitive NMDA Receptor Antagonists [MoA]
Active Ingredients
Dextromethorphan hydrobromide 5 mg/5ml
Route ORAL
Dosage Form SYRUP
RxCUI drug identifier 1090946,
1246254
Application Number M012
Labeler Name Socius Care, LLC
Packages
Package NDC Code Description
70893-0012-0 1 bottle in 1 carton (70893-0012-0) / 118 ml in 1 bottle (70893-0012-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mg

Description

General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
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.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions 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
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients caramel, citric acid, corn syrup, FD and C Red No. 40, flavor, menthol, potassium sorbate, purified water, sodium benzoate, sucrose

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Purpose

Information about the drug product’s indications for use.
Purpose Cough Suppressant

Spl product data elements

Usually a list of ingredients in a drug product.
Creomulsion For Children DEXTROMETHORPHAN HYDROBROMIDE CARAMEL CITRIC ACID MONOHYDRATE CORN SYRUP FD&C RED NO. 40 MENTHOL POTASSIUM SORBATE WATER SODIUM BENZOATE SUCROSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Image of Carton and Label Creomulsion For Children Carton Creomulsion For Children Back Label

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you 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.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments 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

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if 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.

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other Information store at 20-25°C (68-77°F) packaged with tamper evident seal around cap contains no alcohol

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API