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NDC 71205-0100-24 Aprodine 60; 2.5 mg/1; mg/1 Details
Aprodine 60; 2.5 mg/1; mg/1
Aprodine 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; TRIPROLIDINE HYDROCHLORIDE.
Product Information
| NDC | 71205-0100 |
|---|---|
| Product ID | 71205-100_fd421f26-c475-4559-af71-62c1d91f5927 |
| 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 | Aprodine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pseudoephedrine HCl and Tripolidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 60; 2.5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE 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 71205-0100-24 (71205010024)
| NDC Package Code | 71205-100-24 |
|---|---|
| Billing NDC | 71205010024 |
| Package | 1 BLISTER PACK in 1 CARTON (71205-100-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2018-09-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dbd8e15e-7bb0-46b5-9d69-3f8ffaf3bfda 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
- •
- high blood pressure
- •
- heart disease
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
When using this product
- •
- do not exceed recommended dose
- •
- excitability may occur, especially in children
- •
- drowsiness may occur
- •
- avoid alcoholic drinks
- •
- alcohol, sedatives and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
Directions
Other information
Inactive ingredients
Principal Display Panel
MAJOR®
NDC 71205-100-24
Aprodine™
TABLETS
TRIPROLIDINE HCl AND PSEUDOEPHEDRINE HCl
DECONGESTANT/ANTIHISTAMINE/FILM COATED
Head Cold & Allergy Medicine
Relieves:
• Nasal Congestion • Runny Nose
• Sneezing • Itchy, Watery Eyes
24 TABLETS
TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
50844 REV0612M17808
Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Relabeled by
Proficient Rx LP
Thousand Oaks, CA 91320
Re-Order No. 700796
Rev. 09/13
INGREDIENTS AND APPEARANCE
| APRODINE
pseudoephedrine hcl and tripolidine tablet, film coated |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | RELABEL(71205-100) | |