Balamine
FDA Label NDC 63162-508

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ballay Pharmaceuticals, Inc. for the product Balamine (NDC 63162-508). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 5 ml teaspoonful), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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)

Principal Display Panel (473 mL Bottle Label)

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