Endacof Dm - DailyMed Details

Endacof Dm

SPL v13

SPL

SPL Set ID c68ea55a-8b9a-4a70-8b5c-1a2736651813

Route

ORAL

Published

Effective Date 2025-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Brompheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Benzoic Acid Edetate Disodium Fd&c Red No. 40 Propylene Glycol Water Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-03-30

Description

Drug Facts

Purpose

Brompheniramine Maleate Antihistamine Dextromethorphan HBr Antitussive (cough suppressant) Phenylephrine HCl Nasal decongestant

Medication Information

Purpose

Brompheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Phenylephrine HCl Nasal decongestant

Description

Drug Facts

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

cough due to minor throat and bronchial irritation
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily restores freer breathing through the nose

Section 42229-5

Drug Facts

Warnings

Do not use

to sedate a child or make a child sleepy
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or 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 drug.

Directions

Do not exceed 6 doses in a 24-hour period

Age	Dose
Adults and children over 12 years of age:	4 teaspoonsful (20 mL) every 4 hours
Children 6 to under 12 years of age:	2 teaspoonsful (10 mL) every 4 hours
Children under 6 years of age:	Ask your doctor

Other Information

store at 20°-25°C (68°-77°F)
very low sodium, contains 1 mg sodium per teaspoonful (5 mL)

Active Ingredients

(In each 5 mL teaspoonful)

Brompheniramine Maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Inactive Ingredients

Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring

Questions Or Comments

Call 1-601-855-7678 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Principal Display Panel

Figure 1:16 oz. Bottle Label (Front)

When Using This Product

Do not exceed recommended dosage.

marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur.
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a 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 the Reach of Children

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

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other nasal decongestant or stimulant
taking sedatives or tranquilizers

Structured Label Content

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

cough due to minor throat and bronchial irritation
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily restores freer breathing through the nose

Section 42229-5 (42229-5)

Drug Facts

Purpose

Brompheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Phenylephrine HCl Nasal decongestant

Warnings

Do not use

to sedate a child or make a child sleepy
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or 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 drug.

Directions

Do not exceed 6 doses in a 24-hour period

Age	Dose
Adults and children over 12 years of age:	4 teaspoonsful (20 mL) every 4 hours
Children 6 to under 12 years of age:	2 teaspoonsful (10 mL) every 4 hours
Children under 6 years of age:	Ask your doctor

Other Information

store at 20°-25°C (68°-77°F)
very low sodium, contains 1 mg sodium per teaspoonful (5 mL)

Active Ingredients

(In each 5 mL teaspoonful)

Brompheniramine Maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Inactive Ingredients

Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring

Questions Or Comments (Questions or Comments)

Call 1-601-855-7678 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Principal Display Panel

Figure 1:16 oz. Bottle Label (Front)

When Using This Product (When using this product)

Do not exceed recommended dosage.

marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur.
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a 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.

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

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

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
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)

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

taking any other nasal decongestant or stimulant
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves these symptoms due to hay fever (allergic rhinitis): cough due to minor throat and bronchial irritation runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose", "42229-5": "Drug Facts", "Purpose": "Brompheniramine Maleate Antihistamine Dextromethorphan HBr Antitussive (cough suppressant) Phenylephrine HCl Nasal decongestant", "Warnings": "Do not use to sedate a child or make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or 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 drug.", "Directions": "Do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age: 4 teaspoonsful (20 mL) every 4 hours Children 6 to under 12 years of age: 2 teaspoonsful (10 mL) every 4 hours Children under 6 years of age: Ask your doctor", "Other Information": "store at 20°-25°C (68°-77°F) very low sodium, contains 1 mg sodium per teaspoonful (5 mL)", "Active Ingredients": "(In each 5 mL teaspoonful) Brompheniramine Maleate, USP 1 mg Dextromethorphan HBr, USP 5 mg Phenylephrine HCl, USP 2.5 mg", "Inactive Ingredients": "Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring", "Questions or Comments": "Call 1-601-855-7678 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com .", "Principal Display Panel": "Figure 1: 16 oz. Bottle Label (Front)", "When using this product": "Do not exceed recommended dosage. marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur. cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a 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 the reach of children": "In case of overdose, get medical help or contact a Poison Control Center immediately.", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if you are": "taking any other nasal decongestant or stimulant taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:44.999273 · Updated: 2026-03-14T23:13:03.799451