Search by Drug Name or NDC
NDC 71205-0197-24 pseudoephedrine hydrochloride 30 mg/1 Details
pseudoephedrine hydrochloride 30 mg/1
pseudoephedrine hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 71205-0197-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 71205-0197 |
|---|---|
| Product ID | 71205-197_9accf6b7-78b3-4392-b4cd-e3e03fec039c |
| Associated GPIs | 42101020100305 |
| GCN Sequence Number | 005089 |
| GCN Sequence Number Description | pseudoephedrine HCl TABLET 30 MG ORAL |
| HIC3 | B6V |
| HIC3 Description | DECONGESTANTS, ORAL |
| GCN | 20481 |
| HICL Sequence Number | 002091 |
| HICL Sequence Number Description | PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | pseudoephedrine hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/1 |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Proficient Rx LP |
| 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 | 2024-12-31 |
Package
Package Images
NDC 71205-0197-24 (71205019724)
| NDC Package Code | 71205-197-24 |
|---|---|
| Billing NDC | 71205019724 |
| Package | 24 BLISTER PACK in 1 CARTON (71205-197-24) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2019-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a910320b-0585-40bd-928c-0406346281d0 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
|
adults and children 12 years and over |
|
|
children ages 6 to 11 years |
|
|
children under 6 years |
do not use this product in children under 6 years of age |
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hcl tablet, film coated |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(71205-197) , RELABEL(71205-197) | |