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Balamine

Ballay Pharmaceuticals, Inc.

Balamine DM Syrup


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Chlorpheniramine Maleate, USP  2 mg

Dextromethorphan HBr, USP  10 mg

Phenylephrine HCl, USP  5 mg

 Chlorpheniramine Maleate  Antihistamine
 Dextromethorphan HBr  Cough Suppressant
 Phenylephrine HCl  Nasal Decongestant

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
  • 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.
  • 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.

taking sedatives or tranquilizers.

  • 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.
  • 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.

ask a health professional before use.

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

  • do not exceed 6 doses in a 24 hou r 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

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

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

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)

Balamine

Balamine

Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63162-508
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
GLYCERIN
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63162-508-16 473 in 1 BOTTLE
2 20 in 1 BOTTLE
3 NDC:63162-508-20 6 in 1 TRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-04-23


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Be sure to consult your doctor before taking any medication!
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