Basic Care Daytime Nighttime Severe Cold And Flu
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride
L. Perrigo Company
Human Otc Drug
NDC 0113-7301Basic Care Daytime Nighttime Severe Cold And Flu also known as Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride is a human otc drug labeled by 'L. Perrigo Company'. National Drug Code (NDC) number for Basic Care Daytime Nighttime Severe Cold And Flu is 0113-7301. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Basic Care Daytime Nighttime Severe Cold And Flu drug includes . The currest status of Basic Care Daytime Nighttime Severe Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 0113-7301 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Basic Care Daytime Nighttime Severe Cold And Flu |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | L. Perrigo Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 16 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | L. Perrigo Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1110988
1546881
1730211
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0113-7301-90 | 1 KIT in 1 CARTON (0113-7301-90) * 4 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK | 16 Jan, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose - nighttime pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Purpose - daytime pain reliever/fever reducer cough suppressant expectorant nasal decongestant
Product Elements:
Basic care daytime nighttime severe cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride nighttime severe cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine crospovidone (15 mpa.s at 5%) d&c yellow no. 10 fd&c blue no. 1 fd&c blue no. 2 fd&c yellow no. 6 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide stearic acid talc titanium dioxide l5y5 daytime severe cold and flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine croscarmellose sodium crospovidone (15 mpa.s at 5%) fd&c blue no. 2 fd&c red no. 40 maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide stearic acid talc titanium dioxide l922
Indications and Usage:
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: fever nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation headache sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive promotes nasal and/or sinus drainage
Warnings:
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 product allergy alert: acetaminophen 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 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:
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 product allergy alert: acetaminophen 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 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.
When Using:
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
Dosage and Administration:
Directions nighttime and daytime take only as directed - see overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Stop Use:
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.
Package Label Principal Display Panel:
Package/label principal display panel daytime relief compare to vicks ® dayquil ® severe active ingredients non-drowsy daytime severe cold & flu acetaminophen, phenylephrine hcl, dextromethorphan hbr, guaifenesin pain reliever/fever reducer, cough suppressant, expectorant, nasal decongestant alcohol free/antihistamine free max strength actual size 16 caplets nighttime relief compare to vicks ® nyquil ® severe active ingredients nighttime severe cold & flu acetaminophen, phenylephrine hcl, doxylamine succinate, dextromethorphan hbr pain reliever/fever reducer, cough suppressant, antihistamine, nasal decongestant alcohol free max strength actual size 8 caplets daytime nighttime severe cold and flu image
Further Questions:
Questions or comments? 1-800-719-9260