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| Product NDC Code | 69676-0095 | ||||
|---|---|---|---|---|---|
| Drug Name | Daytime and nighttime severe cold and flu combo pack |
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| Type | Brand | ||||
| Route | ORAL | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 2692302, 2693772, 2693777 |
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| Application Number | M013 | ||||
| Labeler Name | Genexa Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg
Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions SHAKE WELL before each use take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 20 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Directions SHAKE WELL before each use take only as directed only use the dose cup provided do not exceed 4 doses per 24 hours adults & children 12 yrs & over 20 mL every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
| adults & children 12 yrs & over | 20 mL every 4 hours |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs |
| adults & children 12 yrs & over | 20 mL every 6 hours |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients organic agave syrup, organic blueberry flavor, natural flavors, purified water, xylitol
Inactive ingredients organic agave syrup, organic blueberry flavor, organic chamomile extract, natural flavors, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation controls the impulse to cough to help you get to sleep
Uses temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever/fever reducer Cough suppressant
Purposes Pain reliever/fever reducer Cough suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Daytime and Nighttime Severe Cold and Flu combo pack Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Daytime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr AGAVE TEQUILANA JUICE WATER XYLITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN BLUEBERRY ACETAMINOPHEN ACETAMINOPHEN Light Nighttime Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate AGAVE TEQUILANA JUICE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER ACETAMINOPHEN ACETAMINOPHEN BLUEBERRY DOXYLAMINE SUCCINATE DOXYLAMINE CHAMOMILE Light
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Day & Night Combo Pack Genexa® MEDICINE MADE CLEAN Daytime Maximum Strength Severe Cold & Flu Acetaminophen - Pain Reliever/Fever Reducer Dextromethorphan HBr - Cough Suppressant Fever Headache Body Aches & Pains Sore Throat Cough Nighttime Severe • Maximum Strength Nighttime Cold & Flu Acetaminophen - Pain Reliever/Fever Reducer Dextromethorphan HBr - Cough Suppressant Doxylamine Succinate - Antihistamine Fever Headache Sore Throat Body Aches & Pains Cough Sneezing Runny Nose Medicine made clean Same effective active ingredients, but no artificial fillers. TWO - 6 FL OZ (177 mL) BOTTLES TOTAL - 12 FL OZ (355 mL) Organic Blueberry Flavor 10052-GNX_R-20240315
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Daytime Severe Cold & Flu Drug Facts
Nighttime Severe Cold & Flu Drug Facts
Tamper evident: Do not use if seal under the cap is disturbed or missing. SHAKE WELL before each use. U.S. Patent No. 11,617,795 | Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com
Made in the USA with globally sourced ingredients NDC 69676-0095-3
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor before use if you have liver disease 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 glaucoma trouble urinating due to enlarged prostate gland
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-436-3921 You may also report side effects to this phone number.
Questions? 1-855-426-3921 You may also report side effects to this phone number.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if pain 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 pain 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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, do not use more than directed.
When using this product 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20-25°C (68-77°F) do not refrigerate
Other information store between 20-25°C (68-77°F) do not refrigerate
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Liver warning: This 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 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. Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema 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. Stop use and ask a doctor if pain 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for 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 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 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. Ask a doctor before use if you have liver disease 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 glaucoma trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product 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 Stop use and ask a doctor if pain 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. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API