Balahist description, usages, side effects, indications, overdosage, supplying and lots more!

Balahist

Ballay Pharmaceuticals, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Balahist DM Syrup

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Brompheniramine Maleate, USP  4 mg

Dextromethorphan HBr, USP  15 mg

Phenylephrine HCl, USP  7.5 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 hour period
 adults and children 12 years of age and over   1 teaspoonful (5 mL) every 4 to 6 hours 
 children 6 years to under 12 years of age  1/2 teaspoonful (2.5 mL) every 4 to 6 hours
 children under 6 years of age  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 63162-520-16

Balahist DM

Syrup

Antihistamine/Decongestant/

Antitussive(Cough Suppressant)

Each teaspoonful (5 mL) for oral

administration contains:

Brompheniramine

Maleate .............................. 4 mg

Dextromethorphan

Hydrobromide .................... 15 mg

Phenylephrine

Hydrochloride ................... 7.5 mg


For Professional Use Only

Sugar Free/Alcohol Free/

Dye Free

BALLAY           16 fl oz. (473 mL)

Balahist

Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63162-520
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 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:63162-520-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-06


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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