NDC 0113-0746 Good Sense Day Time Night Time Cold And Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 0113-0746

NDC Code: 0113-0746

Proprietary Name: Good Sense Day Time Night Time Cold And Flu 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 Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride 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
    • 0113-0746 - Good Sense Day Time Night Time Cold And Flu

NDC 0113-0746-90

Package Description: 1 KIT in 1 CARTON * 8 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK * 4 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Good Sense Day Time Night Time Cold And Flu with NDC 0113-0746 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Day Time Night Time Cold And Flu is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine 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 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.


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.

  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • 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)
  • 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)

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: 03-12-2019 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.

Good Sense Day Time Night Time Cold And Flu Product Label Images

Good Sense Day Time Night Time 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) - Nighttime

Acetaminophen 325 mgDextromethorphan HBr 10 mgDoxylamine succinate 6.25 mgPhenylephrine HCl 5 mg

Active Ingredients (In Each Caplet) - Daytime

Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever/fever reducerCough suppressantAntihistamineNasal decongestant

Purpose - Daytime

Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Uses - Nighttime

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

Uses - Daytime

  • •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 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, 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 - Nighttime

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

Ask A Doctor Before Use If You Have - Daytime

  • •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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are - Nighttime

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

Ask A Doctor Or Pharmacist Before Use If You Are - Daytime

Taking the blood thinning drug warfarin

When Using This Product - Nighttime

  • •do not use more than directed •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 This Product - Daytime

Do not use more than directed

Stop Use And Ask A Doctor If - Nighttime

  • •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.

Stop Use And Ask A Doctor If - Daytime

  • •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 And Daytime

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

Other Information - Nighttime

  • •store at 20-25°C (68-77°F)

Other Information - Daytime

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

Inactive Ingredients - Nighttime

Crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive Ingredients - Daytime

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

* Please review the disclaimer below.

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