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NDC 00485-0202-16 RYNEX PE 1; 2.5 mg/5mL; mg/5mL Details
RYNEX PE 1; 2.5 mg/5mL; mg/5mL
RYNEX PE 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; PHENYLEPHRINE 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: 00485-0202-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 00485-0202-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00485-0202 |
|---|---|
| Product ID | 0485-0202_efbada87-3472-ed2a-e053-2a95a90a08eb |
| Associated GPIs | 43993002201005 |
| GCN Sequence Number | 061050 |
| GCN Sequence Number Description | brompheniramine/phenylephrine SOLUTION 1-2.5 MG/5 ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 27207 |
| HICL Sequence Number | 000443 |
| HICL Sequence Number Description | BROMPHENIRAMINE MALEATE/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | RYNEX PE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BROMPHENIRAMINE MALEATE and Phenylephrine HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 1; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | EDWARDS PHARMACEUTICALS, INC. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00485-0202-16 (00485020216)
| NDC Package Code | 0485-0202-16 |
|---|---|
| Billing NDC | 00485020216 |
| Package | 473 mL in 1 BOTTLE, PLASTIC (0485-0202-16) |
| Marketing Start Date | 2011-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |