Search by Drug Name or NDC
NDC 00485-0254-01 ED A-HIST 4; 10 mg/1; mg/1 Details
ED A-HIST 4; 10 mg/1; mg/1
ED A-HIST is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine 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: 00485-0254-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine
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: 00485-0254-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00485-0254 |
|---|---|
| Product ID | 0485-0254_d57d3921-0855-6640-e053-2a95a90a6116 |
| Associated GPIs | 43993002300315 |
| GCN Sequence Number | 059701 |
| GCN Sequence Number Description | chlorpheniramine/phenylephrine TABLET 4MG-10MG ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 25462 |
| HICL Sequence Number | 000446 |
| HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | ED A-HIST |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 4; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | EDWARDS PHARMACEUTICALS, INC. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 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 00485-0254-01 (00485025401)
| NDC Package Code | 0485-0254-01 |
|---|---|
| Billing NDC | 00485025401 |
| Package | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0254-01) |
| Marketing Start Date | 2011-10-08 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.19352 |
| Pricing Unit | EA |
| Effective Date | 2023-11-22 |
| NDC Description | ED-A-HIST 4 MG-10 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 9147416d-9f3d-4ee4-a0c0-723e29830325 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 the 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 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor |
| Children 6 to under 12 years of age: | 1/2 tablet every 4 hours, not to exceed 3 tablets is 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 0485-0254-01
ED A-HIST TABLETS
Antihistamine • Nasal Decongestant
Each tablet contains:
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
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
chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880) |