BALAMINE DM SYRUP- chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid

Balamine by

Drug Labeling and Warnings

Balamine by is a Otc medication manufactured, distributed, or labeled by Ballay Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

BALAMINE  DM SYRUP
chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63162-508
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/23/2013

Labeler - Ballay Pharmaceuticals, Inc. (035888200)

Establishment
Name	Address	ID/FEI	Business Operations
Ballay Pharmaceuticals, Inc.		035888200	manufacture(63162-508)