Your browser does not support JavaScript! CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.]
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RxNorm Names

CREOMULSION FOR CHILDREN (dextromethorphan hydrobromide) syrup
[Summit Industries, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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.

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

  • Do not take more than 6 doses in any 24 period. Use enclosed dose cup.
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

  • 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 - 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
 
Summit Industries, Inc.

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