NDC 12830-864 Chlo Hist

Chlophedianol Hydrochloride, Dexbrompheniramine Maleate

NDC Product Code 12830-864

NDC 12830-864-04

Package Description: 120 mL in 1 BOTTLE

NDC 12830-864-16

Package Description: 473 mL in 1 BOTTLE

NDC 12830-864-20

Package Description: 20 mL in 1 BOTTLE

NDC Product Information

Chlo Hist with NDC 12830-864 is a a human over the counter drug product labeled by R. A. Mcneil Company. The generic name of Chlo Hist is chlophedianol hydrochloride, dexbrompheniramine maleate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: R. A. Mcneil Company

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.

Chlo Hist 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.

  • CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg/5mL
  • DEXBROMPHENIRAMINE MALEATE 1 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)

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: R. A. Mcneil Company
Labeler Code: 12830
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: 09-15-2014 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.

Chlo Hist Product Label Images

Chlo Hist 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

Active ingredients(in each 5 mL teaspoonful)Chlophedianol Hydrochloride 12.5 mgDexbrompheniramine Maleate 1 mg

Purpose

Cough SuppressantAntihistamine

Indications & Usage

  • Uses A nonnaracotic cough suppressant and antihistamine for the temporary relief of:
  • Cough due to minor throat and bronchial irritationrunny nosesneezingitching of the nose or throatitchy, watery eyes

Warnings

  • Do not exceed recommended dosage.May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.  Use caution when diving a motor vehicle or operating machinery.

Ask A Doctor Before Use If You Have

  • A cough that lasts or is chronic such as occurs with smoking, asthma or emphysemaa cough that occurs with too much phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When Using This Product

  • Excitability may occur, especially in childrenmay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizes may increase the drowsiness effectbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • Cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.new symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or 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.

Directions

Do not exceed recommended dosage.Adults and children


12 years of age


and over:


2 teaspoonfuls (10 mL)


every 6 hours, not to


exceed 4 doses 


in 24 hours


Children 6 to under


12 years of age:


1  teaspoonful


(5 mL) every 6 hours,


not to exceed 4


doses in


24 hours


Children under 6


years of age:


Consult a Physician.

Other Information

Store at 59°-86°F (15°-30°C)

Inactive Ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Product Package Label For 473 Ml

  • NDC 12830-864-16
  • Chlo HIstOral SolutionCough SuppressantAntihistamineGrape FlavorEACH 5 mL (1 TEASPOONFUL) CONTAINS:ChophedianolHydrochloride..................................12.5 mgDexbrompheniramineMaleate................................................1 mgAlcohol Free/Gluten FreeSugar Free/Dye Free
  • ONE PINT (473 mL)
  • Mfg. for R.A. McNeil CompanyChattanooga, TN 37406-3738
  • Rev. 09/17
  • Tamper evident by foil seal under cap. Do notuse if foil seal is broken or missing.
  • Dispense in a tight, light-resistant container
  • With a child-resistant cap.THIS BOTTLE IS NOT TO BE DISPENSED TO
  • THE CONSUMER.
  • Manufactured for:R.A. McNeil Company1150 Latta StreetChattanooga, TN 37406-3738US Patent # 9,050,289Rev. 09/17

* Please review the disclaimer below.