Simucdm elixir

Drug facts

Active Ingredients
(in each 5 mL teaspoonful)

Dextromethorphan
Hydrobromide 25 mg
Guaifenesin 225 mg

Purpose

Antitussive
Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use

  • in a child under 6 years of age
  • if you are now taking a 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 pharmacist before taking this product.

Ask a doctor before use if you have

  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs on a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed 4 doses in 24 hours.

Age
Dose
adults and children 12 years and over
1 teaspoonful (5 mL) every 6-8 hours
children 6 years to under 12 years
1/2 teaspoonful (2.5 mL) every 6-8 hours
children under 6 years
Consult a physician.

Other information

  • store between 20 o-25 oC (68 o-77 oF)

Inactive ingredients

Citric Acid, FD and C Blue #1, FD and C Red #40, Glycerin, Grape Flavor, Propylene Glycol,
Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol.

Questions? comments?

call weekdays from 8 AM to 5 PM CST at 1-800-856-4393. Serious side effects associated
with use of this product may be reported to this number.

Distributed by:
Cypress Pharmaceutical, Inc.
Madison, MS 39110
L515 Rev. 06/09

Ingredients and appearance - Product information

Simucdm elixir- Dextromethorphan hydrobromide and guaifenesin elixir

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 60258-426
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 25 mgin 5 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 225 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Citric acid ( UNII: 2968PHW8QP)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium citrate ( UNII: 1Q73Q2JULR)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Cypress Pharmaceutical, Inc.( 790248942)

Product packaging:

The packaging belows represents the labeling currently used.

NDC 60258-426-16

Simuc-DM
Elixir

Antitussive / Expectorant

Each teaspoonful (5 mL) for oral administration contains:
Dextromethorphan Hydrobromide ... 25 mg
Guaifenesin................................. 225 mg

GRAPE FLAVOR

SUGAR FREE / ALCOHOL FREE

Cypress Pharmaceutical, Inc.

16 fl oz (473 mL)

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant closure.

THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

Mfg. for: Cypress Pharmaceutical, Inc., Madison, MS 39110

L515 Rev. 06/09