FDA Label for Balamine Dm Syrup

Active Ingredients (In Each 5 Ml Teaspoonful)

Chlorpheniramine Maleate, USP  2 mg

Dextromethorphan HBr, USP  10 mg

Phenylephrine HCl, USP  5 mg

Purposes

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 - Bal 001 Label Final