NDC 70518-1836 Diphenhist
Diphenhydramine Hcl
NDC Product Code 70518-1836
Proprietary Name: Diphenhist
What is the Proprietary Name?The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Diphenhydramine Hcl
What is the Non-Proprietary Name?The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Product Characteristics
Color(s):
PINK (C48328 - HALF PINK AND HALF CLEAR WITH WHITE POWDER INSIDE)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
CPC;835
Score: 1
Code Structure
- 70518 - Remedyrepack Inc.
- 70518-1836 - Diphenhist
NDC 70518-1836-0
Package Description: 30 CAPSULE in 1 BLISTER PACK
NDC Product Information
Diphenhist with NDC 70518-1836 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Diphenhist is diphenhydramine hcl. The product's dosage form is capsule and is administered via oral form.
Labeler Name: Remedyrepack Inc.Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Product Type: Human Otc Drug
What kind of product is this?Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Diphenhist Active Ingredient(s)
What is the Active Ingredient(s) List?This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Inactive Ingredient(s)
About the Inactive Ingredient(s)The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
- D&C RED NO. 28 (UNII: 767IP0Y5NH)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GELATIN (UNII: 2G86QN327L)
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
- STARCH, CORN (UNII: O8232NY3SJ)
Administration Route(s)
What are the Administration Route(s)?The translation of the route code submitted by the firm, indicating route of administration.
- Oral - Administration to or by way of the mouth.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Code: 70518
FDA Application Number: part341
What is the FDA Application Number?This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
What is the Marketing Category?Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date: 01-30-2019
What is the Start Marketing Date?This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2020
What is the Listing Expiration Date?This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N
What is the NDC Exclude Flag?This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.
* Please review the disclaimer below.
Diphenhist Product Label Images
Diphenhist Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
- Drug Facts
- Otc - Purpose
- Uses
- Do Not Use
- Ask A Doctor Before Use If You Have
- Ask A Doctor Or Pharmacist Before Use If
- When Using This Product
- If Pregnant Of Breast-Feeding,
- Keep Out Of Reach Of Children.
- Overdosage
- Directions
- Other Information
- Inactive Ingredients
- Other
Drug Facts
Active ingredient (in each banded capsule)Diphenhydramine HCl 25 mg
Otc - Purpose
PurposeAntihistamine
Uses
- Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:runny nose sneezing itchy, watery eyesitching of the nose or throattemporarily relieves these symptoms due to the common cold: runny nose sneezing
Do Not Use
- To make a child sleepywith any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- A breathing problem such as emphysema or chronic bronchitisglaucomatrouble 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
- Marked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when operating machinery or driving a motor vehicleexcitability may occur, especially in children
If Pregnant Of Breast-Feeding,
Ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away: 1-800-222-1222
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away:
1-800-222-1222
Directions
- Take every 4 to 6 hours do not take more than 6 doses in 24 hoursadults and children 12 years of age and over1 to 2 capsuleschildren 6 to under 12 years of age1 capsulechildren under 6 years of agedo not use this product in children under 6 years of age
Other Information
- Store at controlled room temperature 15°-30°C (59°-86°F) in a dry placeprotect from moisturecontains lactose
Inactive Ingredients
D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.
Other
DO NOT USE IF EITHER CAPSULE BAND OR IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDistributed by:
Rugby Laboratories17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152www.rugbylaboratories.com
* Please review the disclaimer below.