DE-CHLOR DM- dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate liquid 
Cypress Pharmaceutical, 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.

----------

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

Purpose

Antitussive
Decongestant
Antihistamine

Uses

temporarily 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 are

taking 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 information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric 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 Packaging

The 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 Packaging

De-Chlor DM Packaging
De-Chlor DM Packaging



DE-CHLOR  DM
dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60258-521
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate2 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric acid monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Maltitol (UNII: D65DG142WK)  
Water (UNII: 059QF0KO0R)  
Sodium citrate, unspecified form (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60258-521-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/201112/11/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/09/201112/11/2014
Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 11/2017
 
Cypress Pharmaceutical, Inc.