CREOMULSION FOR CHILDREN- dextromethorphan hydrobromide syrup 
Summit Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Creomulsion For Children Soothing Cough Syrup Drug Facts

Active Ingredient

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

Purpose

Cough Suppressant

Uses

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

Stop use and ask a doctor if

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Children under 4 yearsdo not use
Children 4 years to under 6 years5ml (1tsp) every 4 hours
Children 6 years to under 12 years10ml (2tsp) every 4 hours
Children 12 years and over20ml (4tsp) every 4 hours

Other Information

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 - Thurs 1-800-241-6996

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 Summit Industries, Inc.

P.O. Box 7329, Marietta, GA 30065

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.



For Adult coughs and colds...

Creomulsion Cough Medicine

Adult Formula

Fast effective relief from coughs due to cold or other bronchial irritations.


Summit Industries, Inc.

P.O. Box 7329

Marietta, GA 30065

creomulsion.com

Image of Carton and Label

CreomulsionChildren.jpgCreomulsion Children Carton CreomulsionChildrenBackLabel.jpgCreomulsion Children Label

CREOMULSION  FOR CHILDREN
dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:12090-0015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
CITRIC ACID MONOHYDRATE 
CORN SYRUP 
FD&C RED NO. 40 
MENTHOL 
POTASSIUM SORBATE 
WATER 
SODIUM BENZOATE 
SUCROSE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12090-0015-01 in 1 CARTON
1NDC:12090-0015-1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34112/30/2009
Labeler - Summit Industries, Inc. (003279189)
Registrant - Summit Industries, Inc. (003279189)
Establishment
NameAddressID/FEIBusiness Operations
Summit Industries, Inc.003279189manufacture(12090-0015)

Revised: 1/2013
Document Id: c861b4d6-30aa-4c71-88a2-b9ae0e094e0f
Set id: 4edc0605-25fc-4a66-8f68-798d1d71446b
Version: 2
Effective Time: 20130121
 
Summit Industries, Inc.