De-Chlor DM

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 15mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL, Chlorpheniramine Maleate 2mg in 5mL
Labeler: Cypress Pharmaceutical, Inc.
NDC Code: 60258-521

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.

De-Chlor DM Liquid

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Dextromethorphan Hydrobromide 15 mg
Phenylephrine Hydrochloride 10 mg
Chlorpheniramine Maleate 2 mg

PurposeAntitussive
Decongestant
Antihistamine

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • swelling of nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat, and itchy, watery eyes

Warnings Do not exceed recommended dosage.

Do not use this product
  • 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
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

When using this product
  • may cause drowsiness
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  These could be signs of a serious condition.
  • new symptoms occur

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

Keep out of the reach of children.In case of accidental overdose seek professional assistance or contact a Poison Control Center immediately.

Directions Do not exceed recommended dosage.
Adults and children
12 years of age
and older:
1 teaspoonful (5 mL) every 4 hours,
not to exceed 6 teaspoonfuls in
24 hours, or as directed by a doctor.
Children 6 to under
12 years of age:

1/2 teaspoonful (2.5 mL) every 4 hours,
not to exceed 3 teaspoonfuls in
24 hours, or as directed by a doctor.
Children under
6 years of age:
Consult a physician.


Other informationStore at 59° - 86°F (15° - 30°C)

Inactive ingredientsCitric Acid, Glycerin, Maltitol, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Strawberry Flavor.

Questions? Comments? 1-800-856-4393
M-F:  8:00 a.m. - 5:00 p.m. CT
Serious side effects associated with use of this product may be reported to this number.

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

l706               Rev. 05/11

Product PackagingThe packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 60258-521-16

De-Chlor DM
Liquid

Antitussive/Decongestant
Antihistamine


Each teaspoonful (5 mL) contains:
Dextromethorphan HBr.......................15 mg
Phenylephrine HCl.............................10 mg
Chlorpheniramine Maleate....................2 mg

DYE FREE / SUGAR FREE
ALCOHOL FREE

Strawberry Flavor

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.

Supplied in a tight, light-resistant container with a child-resistant cap.

THIS BOTTLE SHOULD NOT BE DISPENSED TO THE CONSUMER.

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

L706                   Rev. 05/11









DE-CHLOR  DM
dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60258-521
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate2 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Maltitol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60258-521-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/09/2011
Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 06/2011
 
Cypress Pharmaceutical, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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