NDC 0113-7603 Basic Care Daytime Cold And Flu Severe

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

NDC Product Code 0113-7603

NDC Code: 0113-7603

Proprietary Name: Basic Care Daytime Cold And Flu Severe Additional informationCallout TooltipWhat 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, Guaifenesin, Phenylephrine Hcl Additional informationCallout TooltipWhat 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.


Code Structure
  • 0113 - L. Perrigo Company
    • 0113-7603 - Basic Care Daytime Cold And Flu Severe

NDC 0113-7603-40

Package Description: 1 BOTTLE in 1 CARTON > 355 mL in 1 BOTTLE

NDC Product Information

Basic Care Daytime Cold And Flu Severe with NDC 0113-7603 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Daytime Cold And Flu Severe is acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl. The product's dosage form is solution and is administered via oral form.

Labeler Name: L. Perrigo Company

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Basic Care Daytime Cold And Flu Severe Active Ingredient(s)

Additional informationCallout TooltipWhat 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/15mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL
  • GUAIFENESIN 200 mg/15mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL (UNII: L7T10EIP3A)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SUCROSE (UNII: C151H8M554)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-25-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Basic Care Daytime Cold And Flu Severe Product Label Images

Basic Care Daytime Cold And Flu Severe 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 15 Ml)

Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms: •nasal congestion •sinus congestion and pressure •cough due to minor throat and bronchial irritation •minor aches and pains •headache •fever •sore throat •reduces swelling of nasal passages •temporarily restores freer breathing through the nose •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

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if •adult takes more than 4,000 mg of acetaminophen in 24 hours •child takes more than 5 doses in 24 hours •taken with other drugs containing acetaminophen •adult has 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf 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 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. •if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • •liver disease •heart disease •thyroid disease •diabetes •high blood pressure •trouble urinating due to an enlarged prostate gland •cough that occurs with too much phlegm (mucus) •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin

When Using This Product

Do not use more than directed

Stop Use And Ask A Doctor If

  • •you get nervous, dizzy or sleepless •pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: 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.

Directions

  • •take only as directed – see Overdose warning •only use the dose cup provided •do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use

Other Information

  • •each 15 mL contains: sodium 6 mg •store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

Butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

* Please review the disclaimer below.

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