NDC 42961-051 Histenol Forte Ii

Phenylephrine Hcl, Acetaminophen, Guaifenesin

NDC Product Code 42961-051

NDC CODE: 42961-051

Proprietary Name: Histenol Forte Ii 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: Phenylephrine Hcl, Acetaminophen, Guaifenesin 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 - ROSE PINK)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
ZEE;HF2
Score: 1

NDC Code Structure

  • 42961 - Cintas Corporation

NDC 42961-051-03

Package Description: 125 CARTON in 1 CARTON > 50 PACKET in 1 CARTON (42961-051-02) > 2 TABLET in 1 PACKET (42961-051-01)

NDC Product Information

Histenol Forte Ii with NDC 42961-051 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Histenol Forte Ii is phenylephrine hcl, acetaminophen, guaifenesin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cintas Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Histenol Forte Ii 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.

  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • ACETAMINOPHEN 325 mg/1
  • GUAIFENESIN 100 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE K29/32 (UNII: 390RMW2PEQ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Cintas Corporation
Labeler Code: 42961
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: 01-07-2021 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: 12-31-2022 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 - 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.

Histenol Forte Ii Product Label Images

Histenol Forte Ii 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

Otc - Active Ingredient

Active Ingredient (in each tablet)  Acetaminophen 325 mg, Phenylephrine HCL-5 mg, Guaifenesin-100 mg

Otc - Purpose

Purpose-Pain reliever, Expectorant,Nasal Decongestant

Indications & Usage

  • Uses: temporarily relieves the following cold and flu symptoms:nasal and sinus congestion headache minor aches and painshelps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage & Administration

Directions:adults: take 2 tablets every 4 hours, not more than 12 tablets in 24 hours children under 12 years: ask a doctor

Warnings

  • Warnings:Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productDo not use: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.with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.Ask a doctor before use if you have:heart disease  high blood pressure diabetes liver disease thyroid diseasetrouble urinating due to an enlarged prostate glandcough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysemaAsk a doctor or pharmacist before use if you are taking the blood thinning drug warfarinStop use and ask a doctor if:you get nervous, dizzy or sleeplesspain, nasal congestion or cough gets worse or lasts more than 7 dayscough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.redness or swelling is present in the painful area any new symptoms appear

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a health professional  before use

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.  Prompt medical attention is critical for adults as well as for  children even if you do not notice any signs or symptoms.

Inactive Ingredient

Inactive ingredientsFDC red 40, maltodextrin, microcrystalline cellulose, povidone, silica, sodium starch glycolate, starch, stearic acid

* Please review the disclaimer below.