Active Ingredient
In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mg
Creomulsion Syrup
FDA Label NDC 70893-0012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Socius Care, Llc for the product Creomulsion (NDC 70893-0012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough Suppressant
Uses
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
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.
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.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 |
Other Information
- store at 20-25°C (68-77°F)
- packaged with tamper evident seal around cap
- contains no alcohol
Inactive Ingredients
caramel, citric acid, corn syrup, FD and C Red No. 40, flavor, menthol, potassium sorbate, purified water, sodium benzoate, sucrose
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
Description
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.
* Please review the disclaimer below.
