Algidol Flu

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

Gelpharma S.a. De C.v.
Human Otc Drug
NDC 69377-003

Algidol Flu also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Doxylamine Succinate is a human otc drug labeled by 'Gelpharma S.a. De C.v.'. National Drug Code (NDC) number for Algidol Flu is 69377-003. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Algidol Flu drug includes . The currest status of Algidol Flu drug is Active.

Drug Information:

Drug NDC:	69377-003
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:	Algidol 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, Guaifenesin, Phenylephrine Hydrochloride, Doxylamine Succinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Gelpharma S.a. De C.v.
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:	01 Sep, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Dec, 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:	Gelpharma S.A. de C.V.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1297288 1656815 1657147
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:	0850025476010
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
69377-003-01	1 KIT in 1 CARTON (69377-003-01) / 1 KIT in 1 KIT * 2 CAPSULE in 1 BLISTER PACK (69377-004-01) / 8 CAPSULE in 1 CAPSULE * 1 CAPSULE in 1 BLISTER PACK (69377-005-01) / 8 CAPSULE in 1 CAPSULE	01 Sep, 2022	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:

Purpose pain reliever/fever reducer cough suppressant expectorant nasal decongestant

Purpose pain reliever/fever reducer cough suppressant antihistamine nasal decongestant

Product Elements:

Algidol flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate algidol daytime acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride gelatin water glycerin polyethylene glycol 1000 propylene glycol polyethylene glycol 600 povidone k30 fd&c yellow no. 6 butylated hydroxytoluene butylated hydroxyanisole acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine algidol nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride gelatin water polyethylene glycol 1000 glycerin polyethylene glycol 600 propylene glycol povidone k30 citric acid monohydrate fd&c blue no. 1 fd&c yellow no. 6 butylated hydroxytoluene butylated hydroxyanisole acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine

Indications and Usage:

Uses temporarily relieves minor aches and pains associated with the common cold, sore throat, or headache cough associated with the common cold nasal congestion due to the common cold temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Uses temporarily relieves minor aches and pains associated with the common cold, sore throat, or headache cough associated with the common cold nasal congestion due to the common cold runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever temporarily reduces fever

Warnings:

gh such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. ask a doctor before use if you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed the recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. if pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. 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. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. stop use and ask a doctor if pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if nervousness, dizziness, or sleeplessness occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

gh such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. ask a doctor before use if you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed the recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. because these could be signs of a serious condition. 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. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. avoid alcoholic beverages while taking this product. do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. use caution when driving a motor vehicle or operating machinery. stop use and ask a doctor if pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if nervousness, dizziness, or sleeplessness occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Do Not Use:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 8 capsules in 24 hours, which is the maximum daily amount 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. 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 parkinsonâs 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. for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. ask a doctor before use if you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed the recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. if pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. 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. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. stop use and ask a doctor if pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if nervousness, dizziness, or sleeplessness occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 8 capsules in 24 hours, which is the maximum daily amount 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. 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 parkinsonâs 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. for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. ask a doctor before use if you have liver disease. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed the recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. because these could be signs of a serious condition. 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. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. avoid alcoholic beverages while taking this product. do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. use caution when driving a motor vehicle or operating machinery. stop use and ask a doctor if pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if nervousness, dizziness, or sleeplessness occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

When Using:

When using this product do not exceed the recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. if pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. 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. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

When using this product do not exceed the recommended dosage do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. because these could be signs of a serious condition. 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. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. avoid alcoholic beverages while taking this product. do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. use caution when driving a motor vehicle or operating machinery.

Dosage and Administration:

Directions take only as directed do not exceed 8 capsules per 24 hours adults & children 12 years & over 2 capsules with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years do not use

Stop Use:

Stop use and ask a doctor if pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if nervousness, dizziness, or sleeplessness occur

Package Label Principal Display Panel:

Package labeling: label inner package

Comments/ Reviews:

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