NDC 41226-628 Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl

Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl

NDC Product Code 41226-628

NDC CODE: 41226-628

Proprietary Name: Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl 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, Guailfenesin, Phenlyephrine 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
  • Guaifenesin is used to treat coughs and congestion caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: CAPSULE (C48336)
Size(s):
10 MM
Imprint(s):
78
Score: 1

NDC Code Structure

  • 41226 - Kroger Company
    • 41226-628 - Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl

NDC 41226-628-16

Package Description: 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl with NDC 41226-628 is a a human over the counter drug product labeled by Kroger Company. The generic name of Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl is acetaminophen, dextromethorphan hbr, guailfenesin, phenlyephrine hcl. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Kroger Company

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl 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
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • GUAIFENESIN 200 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 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.

  • GELATIN (UNII: 2G86QN327L)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kroger Company
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: 12-21-2020 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.

Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl Product Label Images

Acetaminophen, Dextromethorphan Hbr, Guailfenesin, Phenlyephrine Hcl 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)acetamnophen 325 mg - Dextromethorphan HBr 10mg - Gualifenesin 200 mg - Phenylephrine HCl 5 mg

Inactive Ingredient

INACTIVE INGREDIENTS

Inactive ingredients: FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Otc - Purpose

PURPOSEPain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Indications & Usage

INDICATIONS & USAGE

temporarily relieves these common cold and flu symptoms: nasal congestion - headache - cough - minor aches and pains - sore throat - temporarily reduces fever - promotes nasal and/or sinus drainage - helps ...
temporarily relieves these common cold and flu symptoms:

nasal congestion

headache

cough

minor aches and pains

sore throat
temporarily reduces fever

promotes nasal and/or sinus drainage

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

DOSAGE & ADMINISTRATIONDirections

Do not take more than directed (see Overdose warning) do not take more than 12 SOFTGELS in any 24-hour period \
adults and children 12 years of age and over: take 2 SOFTGELS every 4 hours

children under 12 years of age: do not use

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Overdose warning - Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center ...
Keep out of reach of children.Overdose warningTaking more than the recommended dose (overdose) may cause liver damage. In 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.

Warnings

Warnings

Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take: more than 12softgels in 24 hours, which is the maximum daily amount - with other drugs ...
Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take:more than 12 softgels in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks daily while using this product
Allergy alertAcetaminophen may cause severe skin reactions. Symptoms may include:skin reddening

blisters

rash
If a skin reaction occurs, stop use and seek medical help right away.Sore 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.

* Please review the disclaimer below.