NDC 69842-692 Cold And Flu Hbp

Acetaminophen, Chlorpheniramine Maleate

NDC Product Code 69842-692

NDC CODE: 69842-692

Proprietary Name: Cold And Flu Hbp 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: Acetaminophen, Chlorpheniramine Maleate 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):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
19 MM
Imprint(s):
44;692
Score: 1

NDC Code Structure

  • 69842 - Cvs Pharmacy

NDC 69842-692-09

Package Description: 2 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Cold And Flu Hbp with NDC 69842-692 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Cold And Flu Hbp is acetaminophen, chlorpheniramine maleate. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Cvs Pharmacy

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Cold And Flu Hbp 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.

  • ACETAMINOPHEN 325 mg/1
  • CHLORPHENIRAMINE MALEATE 2 mg/1

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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Cvs Pharmacy
Labeler Code: 69842
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: 07-16-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 02-21-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Cold And Flu Hbp Product Label Images

Cold And Flu Hbp 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

Active Ingredients (In Each Tablet)

Acetaminophen 325 mgChlorpheniramine maleate 2 mg

Purpose

Pain reliever/fever reducerAntihistamine

Uses

  • Temporarily relieves:headachesneezingrunny noseminor aches and painssore throattemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen: Severe liver damage may occur ifadults take more than 12 tablets in 24 hourschild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blistersrashskin reddening If a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If The User Has

  • Difficulty in urination due to enlargement of the prostate glandliver diseaseglaucomaa breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If The User Is

  • Taking sedatives or tranquilizers taking the blood thinning drug warfarin

When Using This Product

  • Excitability may occur, especially in childrenalcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinerydrowsiness may occuravoid alcoholic beverages

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)new symptoms occurfever gets worse or lasts more than 3 daysredness or swelling is present

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Do not take more than directedadults and children 12 years and over2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours children 6 to under 12 years1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hourschildren under 6 yearsask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENsee end flap for expiration date and lot numberstore at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

Corn starch, crospovidone, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

* Please review the disclaimer below.