BALAMINE DM SYRUP- chlorpheniramine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid 
Ballay Pharmaceuticals, 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.

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Balamine DM Syrup

Drug Facts

Active Ingredients

(in each 5 mL teaspoonful)

Chlorpheniramine Maleate, USP  2 mg

Dextromethorphan HBr, USP  10 mg

Phenylephrine HCl, USP  5 mg

Purposes

 Chlorpheniramine Maleate Antihistamine
 Dextromethorphan HBr Cough Suppressant
 Phenylephrine HCl Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:

  • runny nose
  • nasal congestion
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • relieves cough associated with the common cold

Warnings

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem, or persistent or chronic cough such as occurs with smoking, asthma, emphysema or chronic bronchitis
  • cough accompanied by excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • Do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages.

Stop use and ask a doctor if

  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 7 days, tends to recur, 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 exceed 6 doses in a 24 hour period
 adults and children 12 years and over  2 teaspoonsful (10 mL) every 4 hours 
 children 6 years to under 12 years 1 teaspoonful (5 mL) every 4 hours
 children 2 years to under 6 years 1/2 teaspoonful (2.5 mL) every 4 hours
 children under 2 years ask a doctor

Other information

  • do not use if tamper evident seal under cap is broken or missing
  • store between 20° - 25° C (68° - 77° F).

Inactive Ingredients

citric acid, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, strawberry flavor.

Questions?

call 1-800-847-1921

Manufactured by:

Ballay Pharmaceuticals, Inc.

Wimberley, Texas 78676

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 63162-508-16

Balamine DM

            Syrup

Antihistamine/Decongestant/

Antitussive(Cough Suppressant)

Each teaspoonful (5 mL) for oral

administration contains:

Chlorpheniramine

 Maleate .............................. 2 mg

Dextromethorphan

 Hydrobromide ...................10 mg

Phenylephrine

 Hydrochloride .....................5 mg

For Professional Use Only

Sugar Free/Alcohol Free/

Dye Free

BALLAY                             16 fl oz.

                                         (473 mL)

Principal Display Panel - 473 mL Bottle Label

BALAMINE  DM SYRUP
chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63162-508
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63162-508-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/23/2013
Labeler - Ballay Pharmaceuticals, Inc. (035888200)
Establishment
NameAddressID/FEIBusiness Operations
Ballay Pharmaceuticals, Inc.035888200manufacture(63162-508)

Revised: 4/2013
Document Id: 84eaa263-06bd-43de-aa48-0917d0ee449d
Set id: 9bae052a-2e3f-43c0-bf20-6f2cdf6f1ae5
Version: 1
Effective Time: 20130417
 
Ballay Pharmaceuticals, Inc.