Search by Drug Name or NDC
NDC 10702-0017-54 Chlorphen-12 12 mg/1 Details
Chlorphen-12 12 mg/1
Chlorphen-12 is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by KVK-Tech, Inc.. The primary component is CHLORPHENIRAMINE MALEATE.
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: 10702-0017-54Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine
Product Information
| NDC | 10702-0017 |
|---|---|
| Product ID | 10702-017_7d67f785-a25f-1819-e053-2991aa0a11d3 |
| Associated GPIs | 41100020150410 |
| GCN Sequence Number | 011642 |
| GCN Sequence Number Description | chlorpheniramine maleate TABLET ER 12 MG ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 46541 |
| HICL Sequence Number | 004505 |
| HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE |
| Brand/Generic | Generic |
| Proprietary Name | Chlorphen-12 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Chlorpheniramine Maleate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 12 |
| Active Ingredient Units | mg/1 |
| Substance Name | CHLORPHENIRAMINE MALEATE |
| Labeler Name | KVK-Tech, Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA040829 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 10702-0017-54 (10702001754)
| NDC Package Code | 10702-017-54 |
|---|---|
| Billing NDC | 10702001754 |
| Package | 50 PACKAGE in 1 CARTON (10702-017-54) / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04) |
| Marketing Start Date | 2018-11-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 84409269-fe9b-469e-9a66-27b1475231a3 Details
USES
WARNINGS
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alchohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
Call your doctor for medical advice about side effects.
You may report side effects to FDA at
1-800-FDA-1088
If pregnant or breast-feeding, ask a health professional before use
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
-
calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate
PURPOSE
Principal Display Panel - 24 Tablets Carton
Principal Display panel - 60 Tablets Container Label
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 4 Tablets in a sachet and a carton of 50 sachets
New Look. Same Trusted Ingredient. MADE IN USA
NDC 10702-017-04
NDC 10702-017-54
Chlorphen-12
Allergy
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat
3 in 1
Fast Acting
Long Lasting
Less Drowsy
4 Tablets in a sachet and a carton of 50 sachets
Indoor & Outdoor Allergies
12-hour Extended-Release Tablets
Chlorpheniramine Maleate 12 mg/Antihistamine
INGREDIENTS AND APPEARANCE
| CHLORPHEN-12
chlorpheniramine maleate tablet, film coated, extended release |
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler - KVK-Tech, Inc. (173360061) |
| Registrant - Avanthi, Inc. (832316694) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| KVK-Tech, Inc. | 173360061 | manufacture(10702-017) | |