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Drug Facts

Composition & Product

Active Ingredients

Dexbrompheniramine (1 mg) Pseudoephedrine (30 mg)

Inactive Ingredients

Sodium Citrate Water Sucralose Citric Acid Monohydrate Glycerin Menthol Methylparaben Propylene Glycol Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2007-11-01

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.

Indications and Usage

Other Information:

Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap
Do not use if there is evidence of tampering
WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

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 6 to under 12 years of age	take one 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
glucoma
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, 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

Uses:

Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
Helps decongest sinus openings and sinus passages
Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.

Section 55106-9

Active Ingredients (in each 5 mL tsp.)

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

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

Structured Label Content

Indications and Usage (34067-9)

Other Information:

Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap
Do not use if there is evidence of tampering
WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

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 6 to under 12 years of age	take one teaspoonful (5 mL) every 4 to 6 hours
Children under 6 years of age	ask a doctor

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.

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
glucoma
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, 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)

Uses:

Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
Helps decongest sinus openings and sinus passages
Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.

Section 55106-9 (55106-9)

Active Ingredients (in each 5 mL tsp.)

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

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Other Information: Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap Do not use if there is evidence of tampering WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.", "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 6 to under 12 years of age take one 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 glucoma 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, 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": "Uses: Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies Helps decongest sinus openings and sinus passages Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.", "55106-9": "Active Ingredients (in each 5 mL tsp.) Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information