NDC 0113-7580 Basic Care Daytime Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

NDC Product Code 0113-7580

NDC CODE: 0113-7580

Proprietary Name: Basic Care Daytime Nighttime 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

  • 0113 - L. Perrigo Company
    • 0113-7580 - Basic Care Daytime Nighttime Cold And Flu

NDC 0113-7580-72

Package Description: 1 KIT in 1 CARTON * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Basic Care Daytime Nighttime Cold And Flu with NDC 0113-7580 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Daytime Nighttime Cold And Flu is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl. The product's dosage form is kit and is administered via form.

Labeler Name: L. Perrigo Company

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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)

Product Labeler Information

What 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 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: 04-25-2018 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: 12-31-2020 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.

Basic Care Daytime Nighttime 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

Active Ingredients (In Each Softgel) – Nighttime Cold & Flu

Acetaminophen 325 mgDextromethorphan HBr 15 mgDoxylamine succinate 6.25 mg

Active Ingredients (In Each Softgel) – Daytime Cold & Flu

Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose – Nighttime Cold & Flu

Pain reliever/fever reducerCough suppressantAntihistamine

Purpose – Daytime Cold & Flu

Pain reliever/fever reducerCough suppressantNasal decongestant

Uses – Nighttime Cold & Flu

  • Temporarily relieves common cold/flu symptoms: •cough due to minor throat and bronchial irritation •sore throat •headache •minor aches and pains •fever •runny nose and sneezing

Uses – Daytime Cold & Flu

  • Temporarily relieves common cold/flu symptoms: •nasal congestion •cough due to minor throat and bronchial irritation •sore throat •headache •minor aches and pains •fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 4,000 mg of acetaminophen in 24 hours •with other drugs containing acetaminophen •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, lasts 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 – Nighttime Cold & Flu

  • •liver disease •glaucoma •cough that occurs with too much phlegm (mucus) •a breathing problem such as emphysema or chronic bronchitis •persistent or chronic cough as occurs with smoking, asthma, or emphysema •trouble urinating due to an enlarged prostate gland

Ask A Doctor Before Use If You Have – Daytime Cold & Flu

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

Ask A Doctor Or Pharmacist Before Use If You Are – Nighttime Cold & Flu

  • •taking sedatives or tranquilizers •taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist Before Use If You Are – Daytime Cold & Flu

Taking the blood thinning drug warfarin

When Using This Product – Nighttime Cold & Flu

  • •excitability may occur, especially in children •marked drowsiness may occur •avoid alcoholic drinks •be careful when driving a motor vehicle or operating machinery •alcohol, sedatives, and tranquilizers may increase drowsiness

When Using The Product – Daytime Cold & Flu

Do not use more than directed

Stop Use And Ask A Doctor If – Nighttime Cold & Flu

  • •pain or cough gets worse or lasts more than 7 days •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.

Stop Use And Ask A Doctor If – Daytime Cold & Flu

  • •you get nervous, dizzy or sleepless •pain, nasal congestion or cough gets worse or lasts more than 7 days •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 – Nighttime Cold & Flu

  • •take only as directed – see overdose warning •do not exceed 4 doses per 24 hrsadults & children 12 yrs & over2 softgels with water every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

Directions – Daytime Cold & Flu

  • •take only as directed – see overdose warning •do not exceed 4 doses per 24 hrs adults & children 12 yrs & over2 softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients – Nighttime Cold & Flu

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive Ingredients – Daytime Cold & Flu

Edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

* Please review the disclaimer below.