Balahist Dm Syrup

SPL v1

SPL

SPL Set ID 3434547a-6ef1-496f-93a2-e1c0539ebaaa

Route

ORAL

Published

Effective Date 2013-11-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Brompheniramine (4 mg) Phenylephrine (7.5 mg) Dextromethorphan (15 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Water Sodium Benzoate Sodium Citrate Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-01-06

Description

Brompheniramine Maleate, USP 4 mg Dextromethorphan HBr, USP 15 mg Phenylephrine HCl, USP 7.5 mg

Purpose

Chlorpheniramine Maleate Antihistamine Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant

Medication Information

Purpose

Chlorpheniramine Maleate Antihistamine Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant

Description

Brompheniramine Maleate, USP 4 mg Dextromethorphan HBr, USP 15 mg Phenylephrine HCl, USP 7.5 mg

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

Purposes

Chlorpheniramine Maleate	Antihistamine
Dextromethorphan HBr	Cough Suppressant
Phenylephrine HCl	Nasal Decongestant

Directions

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

Questions?

call 1-800-847-1921

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.

Manufactured By:

Ballay Pharmaceuticals, Inc.

Wimberley, Texas 78676

Active Ingredients

Brompheniramine Maleate, USP 4 mg

Dextromethorphan HBr, USP 15 mg

Phenylephrine HCl, USP 7.5 mg

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.

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.

Keep Out of Reach of Children.

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

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.

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.

Principal Display Panel 473 Ml Bottle Label

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)

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

uses (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

Purposes

Chlorpheniramine Maleate	Antihistamine
Dextromethorphan HBr	Cough Suppressant
Phenylephrine HCl	Nasal Decongestant

Directions

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

Questions?

call 1-800-847-1921

do Not Use (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.

Manufactured By: (Manufactured by:)

Ballay Pharmaceuticals, Inc.

Wimberley, Texas 78676

Active Ingredients

Brompheniramine Maleate, USP 4 mg

Dextromethorphan HBr, USP 15 mg

Phenylephrine HCl, USP 7.5 mg

other Information (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 (Inactive Ingredients)

citric acid, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, strawberry flavor.

when Using This Product (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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.

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

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)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "BROMPHENIRAMINE", "unii": "H57G17P2FN", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purposes": " Chlorpheniramine Maleate Antihistamine Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant", "Directions": "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", "Questions?": "call 1-800-847-1921", "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.", "Manufactured by:": "Ballay Pharmaceuticals, Inc. Wimberley, Texas 78676", "Active Ingredients": "Brompheniramine Maleate, USP 4 mg Dextromethorphan HBr, USP 15 mg Phenylephrine HCl, USP 7.5 mg", "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.", "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.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "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.", "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.", "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label": "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)", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:44.398863 · Updated: 2026-03-14T22:53:39.434183