Search by Drug Name or NDC
NDC 00363-0204-69 Pseudoephedrine Hydrochloride 120 mg/1 Details
Pseudoephedrine Hydrochloride 120 mg/1
Pseudoephedrine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 00363-0204-69Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 00363-0204 |
|---|---|
| Product ID | 0363-0204_d03cb6bb-f193-4cc7-807f-209cdea81efc |
| Associated GPIs | 42101020107405 |
| GCN Sequence Number | 001418 |
| GCN Sequence Number Description | magnesium sulfate CRYSTALS 100 % MISCELL |
| HIC3 | U6W |
| HIC3 Description | BULK CHEMICALS |
| GCN | 04170 |
| HICL Sequence Number | 000610 |
| HICL Sequence Number Description | MAGNESIUM SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Pseudoephedrine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Walgreen Company |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077442 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00363-0204-69 (00363020469)
| NDC Package Code | 0363-0204-69 |
|---|---|
| Billing NDC | 00363020469 |
| Package | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69) |
| Marketing Start Date | 2006-04-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e33d6ca8-7b3c-42ad-85d3-3302a949501e Details
Uses
Warnings
Do not use 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
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton
Walgreens
Compare to the active ingredient in Sudafed® 12 Hour ††
NDC 0363-0204-20
NON-DROWSY
NASAL DECONGESTANT D
PSEUDOEPHEDRINE HCl 120 mg
EXTENDED-RELEASE TABLETS, USP
LONG-ACTING NASAL DECONGESTANT
12 HOUR
MAXIMUM STRENGTH
- •
- SINUS PRESSURE & CONGESTION
20
COATED CAPLETS * (*Capsule – shaped tablets)
120 mg EACH
INGREDIENTS AND APPEARANCE
| PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tablet, film coated, extended release |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Walgreen Company (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 051565745 | MANUFACTURE(0363-0204) | |