Tukol Honey Daytime And Nighttime Value Pack

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Doxylamine Succinate

Genomma Lab Usa
Human Otc Drug
NDC 50066-304

Tukol Honey Daytime And Nighttime Value Pack also known as Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Doxylamine Succinate is a human otc drug labeled by 'Genomma Lab Usa'. National Drug Code (NDC) number for Tukol Honey Daytime And Nighttime Value Pack is 50066-304. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Tukol Honey Daytime And Nighttime Value Pack drug includes . The currest status of Tukol Honey Daytime And Nighttime Value Pack drug is Active.

Drug Information:

Drug NDC:	50066-304
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:	Tukol Honey Daytime And Nighttime Value Pack
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, Phenylephrine Hydrochloride, And Doxylamine Succinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Genomma Lab Usa
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:	30 Jan, 2023
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 May, 2026
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, 2024
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:	Genomma Lab USA
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1043400 1113705 2396898
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.
UPC:	0650240052613
UPC stands for Universal Product Code.
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
50066-304-02	1 KIT in 1 CARTON (50066-304-02) * 1 BOTTLE, PLASTIC in 1 CARTON (50066-302-04) / 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04) / 118 mL in 1 BOTTLE, PLASTIC	30 Jan, 2023	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.

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Purpose:

Active ingredients (in each 15 ml) purpose acetaminophen 325 mg pain reliever/fever reducer dextromethorphan hbr 10 mg cough suppressant phenylephrine hcl 5 mg nasal decongestant

Active ingredients (in each 30 ml) purpose acetaminophen 650 mg pain reliever/fever reducer dextromethorphan hbr 30 mg cough suppressant doxylamine succinate 12.5 mg antihistamine

Product Elements:

Tukol honey daytime and nighttime value pack acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate tukol honey daytime cold and flu acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine water glycerin propylene glycol sorbitol sodium benzoate sucralose amber to yellow tukol honey nighttime cold and flu acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine water glycerin propylene glycol sorbitol sodium benzoate sucralose amber to yellow

Indications and Usage:

Uses temporarily relieves cold/flu symptoms: minor aches and pain headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Uses temporarily relieves cold/flu symptoms: sore throat headache minor aches and pain fever runny nose and sneezing cough due to minor throat and bronchial irritation

Warnings:

r drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) 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 (see overdose warning ) avoid alcoholic drinks stop use and ask a doctor if you get nervous, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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 taking more than the recommended dose may cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not noticve any signs or symptoms.

bitor (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. to make a child sleepy ask a doctor before use if you have liver disease glaucoma; cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland. ask a doctor or pharmacist before use if you are taking sedatives or tranquillizers if you are taking the blood thinning drug warfarin when using this product do not use more than directed avoid alcoholic drinks excitability may occur, especially in children, marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, 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 taking more than the recommended dose may cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not noticve any signs or symptoms.

Do Not Use:

Warnings liver warning the product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product 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 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 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 two 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. with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) 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 (see overdose warning ) avoid alcoholic drinks stop use and ask a doctor if you get nervous, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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 taking more than the recommended dose may cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not noticve any signs or symptoms.

Warnings liver warning the product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product 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 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 for more than 10 days for pain unless directed by a doctor. for more than 3 days for fever unless directed by a doctor 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. to make a child sleepy ask a doctor before use if you have liver disease glaucoma; cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland. ask a doctor or pharmacist before use if you are taking sedatives or tranquillizers if you are taking the blood thinning drug warfarin when using this product do not use more than directed avoid alcoholic drinks excitability may occur, especially in children, marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, 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 taking more than the recommended dose may cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not noticve any signs or symptoms.

When Using:

When using this product do not use more than directed (see overdose warning ) avoid alcoholic drinks

When using this product do not use more than directed avoid alcoholic drinks excitability may occur, especially in children, marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

Dosage and Administration:

Directions take only as recommended (see overdose warning ) use dosage cup do not exceed 4 doses per 24 hours adults and children 12 years and over 30 ml every 4 hours children under 12 years do not use when using day time and night time products, carefully read each label to ensure correct dosing.

Directions take only as recommended see overdose warning use dosage cup do not exceed 4 doses per 24 hours if taking night time at night and day time during the day, limit total to 4 doses per 24 hours. adults and children 12 years and over 30 ml every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Stop Use:

Stop use and ask a doctor if you get nervous, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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 redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel - 118 ml kit carton new tukol Â® honey day time multi symptom value pack cold & flu acetaminophen/ dextromethorphan hbr / phenylephrine hcl ages 12+ natural honey flavor relieves: headache, sore throat, fever minor aches and pains nasal congestion and cough 4 fl oz (118 ml) night time multi symptom acetaminophen/ dextromethorphan hbr / doxylamine succinate ages 12+ natural honey flavor relieves: headache, sore throat, fever minor aches and pains sneezing, runny nose cough 4 fl oz (118 ml) principal display panel - 118 ml kit carton

Further Questions:

Questions or comments? 1-877-994-3666

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.