Rynex Pse

Drug Facts

Composition & Product

Active Ingredients

Brompheniramine (1 mg) Pseudoephedrine (15 mg)

Inactive Ingredients

Citric Acid Monohydrate Fd&c Red No. 40 Fd&c Yellow No. 6 Methylparaben Potassium Citrate Potassium Sorbate Propylparaben Propylene Glycol Water Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: orange

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2011-03-07

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
nasal congestion 'reduces swelling of nasal passages

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50570-1

Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

Section 55105-1

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Brompheniramine Maleate 1 mg	Antihistamine
Pseudoephedrine HCI 15 mg	Decongestant

Warnings

On not exceed recommended dosage.

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over:	4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:	2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours
Children under 6 years of age	Consult a doctor

Other Information

Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]

Question? Comments?

Call 1-800-543-9560

Inactive Ingredients

Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Do Not Use This Product

if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product

When Using This Product

excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask Doctor If

nervousness, dizziness, or sleeplessness occur
If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
new symptoms occur

Principal Display Panel 473 Ml Bottle Label

NDC 00485-0206-16

Rynex PSE

Antihistamine • Decongestant

Sugar Free • Alcohol Free •

Gluten Free

Each teaspoonful (5 mL)

for oral administration contains:

Brompheniramine Maleate 1 mg

Pseudoephedrine HCI 15 mg

Orange Flavor

FOR PROFESSIONAL USE ONLY

This bottle is not to be

dispensed to consumer.

Tamper evident by foil seal under cap.

Do not used foil seal is broken or missing.

Dispense in a tight container with a child-

resistant cap.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

16oz. (473 mL)

Do Not Use This Product, Unless Directed By A Doctor, If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
thyroid disease
diabetes mellitus
difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
nasal congestion 'reduces swelling of nasal passages

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50570-1 (50570-1)

Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

Section 55105-1 (55105-1)

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Brompheniramine Maleate 1 mg	Antihistamine
Pseudoephedrine HCI 15 mg	Decongestant

Warnings

On not exceed recommended dosage.

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over:	4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:	2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours
Children under 6 years of age	Consult a doctor

Other Information (Other information)

Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]

Question? Comments?

Call 1-800-543-9560

Inactive Ingredients (Inactive ingredients)

Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Do Not Use This Product (Do not use this product)

if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product

When Using This Product (When using this product)

excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask Doctor If (Stop use and ask doctor If)

nervousness, dizziness, or sleeplessness occur
If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
new symptoms occur

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

NDC 00485-0206-16

Rynex PSE

Antihistamine • Decongestant

Sugar Free • Alcohol Free •

Gluten Free

Each teaspoonful (5 mL)

for oral administration contains:

Brompheniramine Maleate 1 mg

Pseudoephedrine HCI 15 mg

Orange Flavor

FOR PROFESSIONAL USE ONLY

This bottle is not to be

dispensed to consumer.

Tamper evident by foil seal under cap.

Do not used foil seal is broken or missing.

Dispense in a tight container with a child-

resistant cap.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

16oz. (473 mL)

Do Not Use This Product, Unless Directed By A Doctor, If You Have (Do not use this product, unless directed by a doctor, if you have)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
thyroid disease
diabetes mellitus
difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion 'reduces swelling of nasal passages", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.", "50570-1": "Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.", "55105-1": "Active Ingredients (in each 5 mL teaspoonful) Purpose Brompheniramine Maleate 1 mg Antihistamine Pseudoephedrine HCI 15 mg Decongestant", "Warnings": "On not exceed recommended dosage.", "Directions": "Do not exceed recommended dosage Adults and children 12 years of age and over: 4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours Children under 6 years of age Consult a doctor", "Other information": "Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]", "Question? Comments?": "Call 1-800-543-9560", "Inactive ingredients": "Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose", "Do not use this product": "if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product", "When using this product": "excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery", "Stop use and ask doctor If": "nervousness, dizziness, or sleeplessness occur If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor new symptoms occur", "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label": "NDC 00485-0206-16 Rynex PSE Antihistamine • Decongestant Sugar Free • Alcohol Free • Gluten Free Each teaspoonful (5 mL) for oral administration contains: Brompheniramine Maleate 1 mg Pseudoephedrine HCI 15 mg Orange Flavor FOR PROFESSIONAL USE ONLY This bottle is not to be dispensed to consumer. Tamper evident by foil seal under cap. Do not used foil seal is broken or missing. Dispense in a tight container with a child- resistant cap. Manufactured for: EDWARDS Pharmaceuticals, Inc. Ripley, MS 38663 16oz. (473 mL)", "Do not use this product, unless directed by a doctor, if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information