NDC 0113-7951 Basic Care Daytime Severe Cold Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride

NDC Product Code 0113-7951

NDC CODE: 0113-7951

Proprietary Name: Basic Care Daytime Severe Cold 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 Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride 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
    • 0113-7951 - Basic Care Daytime Severe Cold Nighttime Cold And Flu

NDC 0113-7951-81

Package Description: 1 KIT in 1 KIT * 10 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK * 5 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Basic Care Daytime Severe Cold Nighttime Cold And Flu with NDC 0113-7951 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Daytime Severe Cold Nighttime Cold And Flu is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride. 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 01-24-2019 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 Severe Cold 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 Caplet) - Day Time Severe Cold

Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Active Ingredients (In Each Caplet) – Night Time Cold & Flu

Acetaminophen 325 mgDiphenhydramine HCl 25 mgPhenylephrine HCl 5 mg

Purposes - Day Time Severe Cold

Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Purposes - Night Time Cold & Flu

Pain reliever/fever reducerAntihistamineNasal decongestant

Uses

  • •temporarily relieves these common cold and flu symptoms: •nasal congestion •cough (DAY TIME Severe Cold only) •minor aches and pains •headache •sore throat •runny nose and sneezing (NIGHT TIME Cold & Flu only) •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME Severe Cold only) •temporarily reduces fever

Warnings

  • Liver warning: These products contain 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 these productsAllergy 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. •with any other product containing diphenhydramine, even one used on skin (NIGHT TIME Cold & Flu only) •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 these products. •if you have ever had an allergic reaction to these products or any of their ingredients

Ask A Doctor Before Use If You Have

  • •liver disease •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •glaucoma (NIGHT TIME Cold & Flu only) •a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME Cold & Flu only) •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME Severe Cold only) •cough that occurs with too much phlegm (mucus) (DAY TIME Severe Cold only)

Ask A Doctor Or Pharmacist Before Use If You Are

  • •taking the blood thinning drug warfarin •taking sedatives or tranquilizers (NIGHT TIME Cold & Flu only)

When Using These Products

  • •do not use more than directed •excitability may occur, especially in children (NIGHT TIME Cold & Flu only) •marked drowsiness may occur (NIGHT TIME Cold & Flu only) •alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME Cold & Flu only) •avoid alcoholic drinks (NIGHT TIME Cold & Flu only) •be careful when driving a motor vehicle or operating machinery (NIGHT TIME Cold & Flu only)

Stop Use And Ask A Doctor If

  • •nervousness, dizziness, or sleeplessness occur •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. (DAY TIME Severe Cold only)

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

  • •do not take more than directed (see Overdose warning) •do not take more than 10 caplets in any 24-hour period •adults and children 12 years of age and older: take 2 caplets every 4 hours •children under 12 years of age: do not use

Other Information

  • •each caplet contains: sodium 4 mg (DAY TIME Severe Cold only) •store at 20-25°C (68-77°F)

Inactive Ingredients - Day Time Severe Cold

Croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive Ingredients – Night Time Cold & Flu

Crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

* Please review the disclaimer below.