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Drug Facts

Composition & Product

Active Ingredients

dexbrompheniramine (2 mg) pseudoephedrine (60 mg)

Inactive Ingredients

calcium phosphate, dibasic, anhydrous cellulose, microcrystalline magnesium stearate sodium starch glycolate type b potato water ferric oxide red ferric oxide yellow titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: LLORENS Shape: oval Color: white Size: 13 mm Score: 1

Marketing Status

otc monograph drug active Since 2007-11-01

Medication Information

Warnings and Precautions

Warnings:

Ask a doctor before you use if you are

taking sedatives or tranquilizers.

Ask your doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
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 doctor if

nervousness, dizziness or sleepiness occur
symptoms do not improve withing 7 days or occur with a fever

Active Ingredient

Active Ingredients (in each film coated tablet) Purpose

Dexbrompheniramine Maleate, USP ................ 2 mg .................. Antihistamine

Pseudeophedrine HCl, USP .................... 60 mg ..........................Nasal Decogestant

Indications and Usage

Other Information:Store at controlled room temperature 20 - 25 degree celsius (68 - 77 degree fahrenheit); excursions permitted to

15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal

under cap. Do not use if there is evidence of tampering.

Dosage and Administration

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

Adults and children 12 years of age and over	Take one tablet every 6 hours
Children 6 to under 12 years of age	1/2 tablet every 4 to 6 hours
Children under 6 years of age	Ask a doctor

Description

Active Ingredients (in each film coated tablet) Purpose Dexbrompheniramine Maleate, USP ................ 2 mg .................. Antihistamine Pseudeophedrine HCl, USP .................... 60 mg ..........................Nasal Decogestant

Section 43683-2

Fixed typographical error in Dosification directions

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

Do not useif 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 MAOI;

ask your doctor or pharmacist before taking this product.

Section 51727-6

Inactive Ingredients:Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Silicon dioxide

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 the 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 symptoms due to hay fever (allergic rhinitis): runny nose, sneezing, itching of the nose or throat, itching and watery eyes.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

Ask a doctor before you use if you are

taking sedatives or tranquilizers.

Ask your doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
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 doctor if

nervousness, dizziness or sleepiness occur
symptoms do not improve withing 7 days or occur with a fever

Active Ingredient (55106-9)

Active Ingredients (in each film coated tablet) Purpose

Dexbrompheniramine Maleate, USP ................ 2 mg .................. Antihistamine

Pseudeophedrine HCl, USP .................... 60 mg ..........................Nasal Decogestant

Indications and Usage (34067-9)

Other Information:Store at controlled room temperature 20 - 25 degree celsius (68 - 77 degree fahrenheit); excursions permitted to

15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal

under cap. Do not use if there is evidence of tampering.

Dosage and Administration (34068-7)

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

Adults and children 12 years of age and over	Take one tablet every 6 hours
Children 6 to under 12 years of age	1/2 tablet every 4 to 6 hours
Children under 6 years of age	Ask a doctor

Section 43683-2 (43683-2)

Fixed typographical error in Dosification directions

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)

Do not useif 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 MAOI;

ask your doctor or pharmacist before taking this product.

Section 51727-6 (51727-6)

Inactive Ingredients:Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Silicon dioxide

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 the 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 symptoms due to hay fever (allergic rhinitis): runny nose, sneezing, itching of the nose or throat, itching and watery eyes.

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 celsius (68 - 77 degree fahrenheit); excursions permitted to 15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.", "34068-7": "Directions: Do not exceed more than 4 tablets in any 24-hour period or as directed by a doctor. Adults and children 12 years of age and over Take one tablet every 6 hours Children 6 to under 12 years of age 1/2 tablet every 4 to 6 hours Children under 6 years of age Ask a doctor", "34071-1": "Warnings: Ask a doctor before you use if you are taking sedatives or tranquilizers. Ask your doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma 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 doctor if nervousness, dizziness or sleepiness occur symptoms do not improve withing 7 days or occur with a fever", "43683-2": "Fixed typographical error in Dosification directions", "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": "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 MAOI; ask your doctor or pharmacist before taking this product.", "51727-6": "Inactive Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Silicon dioxide", "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 the 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 symptoms due to hay fever (allergic rhinitis): runny nose, sneezing, itching of the nose or throat, itching and watery eyes.", "55106-9": "Active Ingredients (in each film coated tablet) Purpose Dexbrompheniramine Maleate, USP ................ 2 mg .................. Antihistamine Pseudeophedrine HCl, USP .................... 60 mg ..........................Nasal Decogestant"}