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NDC 00485-0210-01 ED-A-HIST PSE 60; 2.5 mg/1; mg/1 Details
ED-A-HIST PSE 60; 2.5 mg/1; mg/1
ED-A-HIST PSE is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
| NDC | 00485-0210 |
|---|---|
| Product ID | 0485-0210_d57f830b-52d0-0fd2-e053-2995a90a8a7a |
| Associated GPIs | 43993002800330 |
| GCN Sequence Number | 001151 |
| GCN Sequence Number Description | triprolidine/pseudoephedrine TABLET 2.5MG-60MG ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 96445 |
| HICL Sequence Number | 000505 |
| HICL Sequence Number Description | TRIPROLIDINE HCL/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | ED-A-HIST PSE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 60; 2.5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE 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 00485-0210-01 (00485021001)
| NDC Package Code | 0485-0210-01 |
|---|---|
| Billing NDC | 00485021001 |
| Package | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01) |
| Marketing Start Date | 2011-10-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b0c6ef78-0f82-4ff7-a988-b11f99094843 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 (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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
- difficulty in urination due to enlargement of the prostate gland
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: | 1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor |
| Children 6 to under 12 years of age: | 1/2 tablet every 4-6 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor |
| Children under 6 years of age: | Consult a doctor. |
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
NDC 00485-0210-01
ED A-HIST PSE TABLETS
Nasal Decongestant • Antihistamine
Each tablet contains:
Pseudoephedrine HCI 60 mg
Triprolidine HCI 2.5 mg
This bottle is not to be dispensed to consumer.
Dispense in a tight, light-resistant container
with a child-resistant cap.
Store at 59°-86°F (15°-30°C) (see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Manufactured for:
EDWARDS
Pharmaceuticals, Inc .
Ripley, MS 38663
100 tablets
INGREDIENTS AND APPEARANCE
| ED-A-HIST PSE
pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated |
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| Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880) |
Revised: 1/2022
Document Id: d57f830b-52d0-0fd2-e053-2995a90a8a7a
Set id: b0c6ef78-0f82-4ff7-a988-b11f99094843
Version: 4
Effective Time: 20220113