NDC 76281-315 Childrens Nighttime Cold And Cough

Diphenhydramine Hcl, Phenylephrine Hcl

NDC Product Code 76281-315

NDC 76281-315-26

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Childrens Nighttime Cold And Cough with NDC 76281-315 is a a human over the counter drug product labeled by Aptapharma Inc.. The generic name of Childrens Nighttime Cold And Cough is diphenhydramine hcl, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Aptapharma Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Childrens Nighttime Cold And Cough 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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 Name: Aptapharma Inc.
Labeler Code: 76281
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: 08-01-2018 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: 12-31-2021 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.

Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Childrens Nighttime Cold And Cough Product Label Images

Childrens Nighttime Cold And Cough 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (in each 5 mL)Diphenhydramine HCI, USP              6.25 mg Phenylephrine HCI, USP                    2.5 mg

Otc - Purpose

PurposeDiphenhydramine HCI, USP                 Antihistamine/Cough suppressantPhenylephrine HCI, USP                      Nasal decongestant

Indications & Usage

Uses• temporarily controls cough due to minor throat and bronchial   irritation and relieves nasal congestion as may occur with a cold• temporarily relieves the following symptoms due to hay fever or   other upper respiratory allergies:          • sneezing                  • runny nose          • itchy, watery eyes     • itchy nose or throat

Warnings

WarningsDo not use• with any other product containing diphenhydramine, even  one used on the skin• to make a child sleepy• 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.

Otc - Ask Doctor

Ask a doctor before use if the child has• heart disease          • high blood pressure         •thyroid disease• diabetes                 • glaucoma• abreathing problem such as chronic bronchitis• persistent or chronic cough such as occurs with asthma• cough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is• taking sedatives or tranquilizers.

Otc - When Using

When using this product• do not use more than directed• excitability may occur, especially in children• marked drowsiness may occur• sedatives and tranquilizers may increase drowsiness

Otc - Stop Use

Stop use and ask a doctor if• nervousness, dizziness or sleeplessness occur• symptoms do not get better within 7 days or occur with fever• cough lasts more than 7 days, comes back, or occurswith fever, rash, or persistent headache.These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions do not use more than directed do not take more than 6 doses in any 24-hour period mL=milliliterAge                                                          Dose  Children 6 to under 12 years of age 10 mL every 4 hours Children 4 to under 6 years of age Do not use unless directed by a doctor Children under 4 years of age Do not use

Other Safety Information

Other information• each 10 mL contains: sodium 3 mg• store between 20-25°C (68-77°F)• do not refrigerate• dosing cup provided

Inactive Ingredient

Inactive ingredientsanhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

* Please review the disclaimer below.