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NDC 00485-0206-16 RYNEX PSE 1; 15 mg/5mL; mg/5mL Details
RYNEX PSE 1; 15 mg/5mL; mg/5mL
RYNEX PSE is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00485-0206-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 00485-0206-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 00485-0206 |
|---|---|
| Product ID | 0485-0206_19ac8a3a-6e5f-4c5d-93f0-9aba74ef22f6 |
| Associated GPIs | 43993002241003 |
| GCN Sequence Number | 047576 |
| GCN Sequence Number Description | brompheniramin/pseudoephedrine LIQUID 1-15MG/5ML ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 12933 |
| HICL Sequence Number | 000501 |
| HICL Sequence Number Description | BROMPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | RYNEX PSE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 1; 15 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | EDWARDS PHARMACEUTICALS, INC. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00485-0206-16 (00485020616)
| NDC Package Code | 0485-0206-16 |
|---|---|
| Billing NDC | 00485020616 |
| Package | 473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) |
| Marketing Start Date | 2011-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2f2d9b5a-f66b-4928-8d43-402ef9efcfdf Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Do not exceed recommended dosage.
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
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
Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
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
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 |
Inactive ingredients
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)
INGREDIENTS AND APPEARANCE
| RYNEX PSE
brompheniramine maleate and pseudoephedrine hydrochloride liquid |
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| Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880) |