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NDC 70000-0164-01 Pseudoephedrine Hydrochloride 120 mg/1 Details
Pseudoephedrine Hydrochloride 120 mg/1
Pseudoephedrine Hydrochloride is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. 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: 70000-0164-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 70000-0164 |
|---|---|
| Product ID | 70000-0164_2729ed53-f924-47da-b2e8-31fe5851ce90 |
| Associated GPIs | 42101020107405 |
| GCN Sequence Number | 016937 |
| GCN Sequence Number Description | pseudoephedrine HCl TABLET ER 120 MG ORAL |
| HIC3 | B6V |
| HIC3 Description | DECONGESTANTS, ORAL |
| GCN | 26901 |
| 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 Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Cardinal Health |
| 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 70000-0164-01 (70000016401)
| NDC Package Code | 70000-0164-1 |
|---|---|
| Billing NDC | 70000016401 |
| Package | 10 TABLET, EXTENDED RELEASE in 1 CARTON (70000-0164-1) |
| Marketing Start Date | 2017-02-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b8ff40d6-d44c-444e-975f-5fd481578332 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
NDC 70000-0164-1
LEADER™
NON-DROWSY | MAXIMUM STRENGTH
12 Hour Nasal Decongestant
Pseudoephedrine Hydrochloride, 120 mg | Long-Acting Nasal Decongestant
Extended-Release Tablets, USP
12 Hour
SINUS PRESSURE + CONGESTION
COMPARE TO
SUDAFED® 12 HOUR
active ingredient*
100% Money
Back Guarantee
10 COATED CAPSULE-SHAPED TABLETS 120 mg EACH
INGREDIENTS AND APPEARANCE
| PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tablet, extended release |
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| Labeler - Cardinal Health (097537435) |
| Registrant - Ohm Laboratories Inc. (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 051565745 | MANUFACTURE(70000-0164) | |