Label: CREOMULSION FOR CHILDREN- dextromethorphan hydrobromide syrup
- NDC Code(s): 12090-0015-0, 12090-0015-1
- Packager: Summit Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated January 21, 2013
If you are a consumer or patient please visit this version.
- Active Ingredient
In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mgClose
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
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.Close
- 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.Close
- 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.Close
- Do not take more than 6 doses in any 24 period. Use enclosed dose cup.
Children under 4 years do not use Children 4 years to under 6 years 5ml (1tsp) every 4 hours Children 6 years to under 12 years 10ml (2tsp) every 4 hours Children 12 years and over 20ml (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, sucroseClose
- 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 30065Close
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
Fast effective relief from coughs due to cold or other bronchial irritations.
Summit Industries, Inc.
P.O. Box 7329
Marietta, GA 30065
- 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:12090-0015 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:12090-0015-0 1 in 1 CARTON 1 NDC:12090-0015-1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part341 12/30/2009 Labeler - Summit Industries, Inc. (003279189) Registrant - Summit Industries, Inc. (003279189) Establishment Name Address ID/FEI Business Operations Summit Industries, Inc. 003279189 manufacture(12090-0015)