NDC 41226-627 Daytime-nighttime Severe Cold And Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

NDC Product Code 41226-627

NDC CODE: 41226-627

Proprietary Name: Daytime-nighttime Severe Cold And Flu 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, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine 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.

NDC Code Structure

  • 41226 - Kroger
    • 41226-627 - Daytime-nighttime Severe Cold And Flu

NDC 41226-627-24

Package Description: 24 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Daytime-nighttime Severe Cold And Flu with NDC 41226-627 is a a human over the counter drug product labeled by Kroger. The generic name of Daytime-nighttime Severe Cold And Flu is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl. The product's dosage form is kit and is administered via oral form.

Labeler Name: Kroger

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • GELATIN (UNII: 2G86QN327L)
  • SHELLAC (UNII: 46N107B71O)
  • POVIDONE (UNII: FZ989GH94E)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GELATIN (UNII: 2G86QN327L)
  • SHELLAC (UNII: 46N107B71O)
  • SORBITOL (UNII: 506T60A25R)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • POVIDONE (UNII: FZ989GH94E)

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.
  • 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: Kroger
Labeler Code: 41226
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: 05-29-2020 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.

Daytime-nighttime Severe Cold And Flu Product Label Images

Daytime-nighttime Severe Cold And Flu 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 ingredients (in each softgel)ACETAMINOPHEN 325MGD0EXTROMETHORHAN HBR10 MG,GUAIFENESIN 200 MG, PHENYLEPHRINE HCL 5 MG

3 (in each softgel)

Acetaminophen 325mg

Dextromethorphan HBR 10 mgDoxylamine Succinate 6.25 mg PhenylephrineHCl,

Indications & Usage

  • Temporarily relieves common cold/flu symptoms:nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationminor aches & painsheadachefeversore throatreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

  • PurposePain reliever/Fever reducerCough suppressantAntihistamineNasal decongestant

Warnings

Warnings

Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels
This product contains acetaminophen.Severe liver damage may occur if you takemore than 8 LiquiCaps in 24 hrs, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product
Allergy Alert:Acetaminophen may cause severe skin reactions. Symptoms may include:Skin reddening

Blisters

Rash
If a skin reaction occurs, stop use and seek medical help right awaySore 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.

Warnings

Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product - with other ...
This product contains acetaminophen.Severe liver damage may occur if you takemore than 8 softgels in 24 hrs, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product
Allergy Alert:Acetaminophen may cause severe skin reactions. Symptoms may include:Skin reddening

Blisters

Rash
If a skin reaction occurs, stop use and seek medical help right awaySore throat warningIf 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.

Inactive Ingredient

FD&C Blue No.1,FD&C Red No. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Dosage & Administration

  • Directions
  • Take only as directed - do not exceed 8 Softgels per 24 hrs -
  • Adults & children 12 yrs & over 2 Softgels with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not use

Directions

take only as directed - do not exceed 8 softgels per 24 hours -
adults & children 12 yrs & over 2 softgels with water every 6 hrs -children 4 to under 12 yrs ask a doctor -children under 4 yrs do not use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warningIn case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children.Overdose warningIn case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Otc - Purpose

PAIN RELIEVER-FEVER REDUCERCOUGH SUPPRESENTMINOR ACHES AND PAINSCHEST CONGESTION

MINOR ACHES AND PAINS, FEVERNASAL CONGESTION AND SINUS PRESSURESNEEZING, RUNNY NOSECOUGH

Minor Aches & Pains

Nasal/Sinus Congestion

& Sinus Pressure

Sneezing, Runny Nose

Cough

* Please review the disclaimer below.