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Drug Facts

Composition & Product

Active Ingredients

dexbrompheniramine (1 mg) pseudoephedrine (30 mg)

Inactive Ingredients

citric acid monohydrate glycerin menthol methylparaben water propylene glycol propylparaben sodium citrate sucralose

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-12-01

Medication Information

Warnings and Precautions

Warnings:

Do not use ifyou are 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 you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.

Active Ingredient

Active Ingredients (in each 5 mL tsp.)

Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine

Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant

Indications and Usage

Uses

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper repiratory allergies
helps decongest sinus opening and sinus passages
reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
temporarily alleviates the following symptoms due to hay fever (allergic rhinitis)
runny nose
sneezing
itching of the nose or throat
ithy and watery eyes

Dosage and Administration

Directions:Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

Age	Dose
Adults and children 12 years of age and over	take two teaspoonfuls (10 mL) every 4 to 6 hours
Children under 12 years of age	take 1 teaspoonful (5 mL) every 4 to 6 hours
Children under 6 years of age	ask a doctor

Description

Active Ingredients (in each 5 mL tsp.) Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant

Section 50565-1

Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1

Ask a doctor before use if you aretaking sedatives or tranquilizers.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disese
diabetes
difficulty in urination due to the enlargement of the prostate gland.

When using this product

do not exceed the recommended dosage
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever.

Section 51727-6

Inactive Ingredients: citric acid, flavor, glycerine, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

Section 51945-4

Section 53413-1

Questions or Comments? 1-866-595-5598

Section 53414-9

If pregnant or breast-feeding,ask a Health Professional before use.

Section 55105-1

Antihistamine

Nasal Decongestant

Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

Do not use ifyou are 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 you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.

Active Ingredient (55106-9)

Active Ingredients (in each 5 mL tsp.)

Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine

Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant

Indications and Usage (34067-9)

Uses

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper repiratory allergies
helps decongest sinus opening and sinus passages
reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
temporarily alleviates the following symptoms due to hay fever (allergic rhinitis)
runny nose
sneezing
itching of the nose or throat
ithy and watery eyes

Dosage and Administration (34068-7)

Directions:Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

Age	Dose
Adults and children 12 years of age and over	take two teaspoonfuls (10 mL) every 4 to 6 hours
Children under 12 years of age	take 1 teaspoonful (5 mL) every 4 to 6 hours
Children under 6 years of age	ask a doctor

Section 50565-1 (50565-1)

Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Ask a doctor before use if you aretaking sedatives or tranquilizers.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disese
diabetes
difficulty in urination due to the enlargement of the prostate gland.

When using this product

do not exceed the recommended dosage
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever.

Section 51727-6 (51727-6)

Inactive Ingredients: citric acid, flavor, glycerine, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? 1-866-595-5598

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a Health Professional before use.

Section 55105-1 (55105-1)

Antihistamine

Nasal Decongestant

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Temporarily relieves nasal congestion due to the common cold, hay fever or other upper repiratory allergies helps decongest sinus opening and sinus passages reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose temporarily alleviates the following symptoms due to hay fever (allergic rhinitis) runny nose sneezing itching of the nose or throat ithy and watery eyes", "34068-7": "Directions: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor. Age Dose Adults and children 12 years of age and over take two teaspoonfuls (10 mL) every 4 to 6 hours Children under 12 years of age take 1 teaspoonful (5 mL) every 4 to 6 hours Children under 6 years of age ask a doctor", "34071-1": "Warnings: Do not use if you are 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 you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.", "50565-1": "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50570-1": "Ask a doctor before use if you are taking sedatives or tranquilizers. Ask a doctor before use if you have heart disease high blood pressure thyroid disese diabetes difficulty in urination due to the enlargement of the prostate gland. When using this product do not exceed the recommended dosage excitability may occur, especially in children drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or occur with a fever.", "51727-6": "Inactive Ingredients: citric acid, flavor, glycerine, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose", "53413-1": "Questions or Comments? 1-866-595-5598", "53414-9": "If pregnant or breast-feeding, ask a Health Professional before use.", "55105-1": "Antihistamine Nasal Decongestant", "55106-9": "Active Ingredients (in each 5 mL tsp.) Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant"}