CREOMULSION FOR CHILDREN- dextromethorphan hydrobromide syrup

Creomulsion by

Drug Labeling and Warnings

Creomulsion by is a Otc medication manufactured, distributed, or labeled by Socius Care, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mg

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.

PREGNANCY OR BREAST FEEDING

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

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.

Image of Carton and Label

INGREDIENTS AND APPEARANCE

CREOMULSION  FOR CHILDREN
dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70893-0012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70893-0012-0	1 in 1 CARTON	08/11/2016
1	NDC: 70893-0012-1	118 mL in 1 BOTTLE; Type 6: Drug/Biologic Combination

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/11/2016

Labeler - Socius Care, LLC (079946712)