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| Product NDC Code | 82706-016 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Axiv nighttime |
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| Type | Brand | ||||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||||
| RxCUI drug identifier | 1094549 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | VIVUNT PHARMA LLC | ||||||
| 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 softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
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 Take only as directed (see overdose warning) Do not take more than 8 Softgels in 24 hours adults & children 12 years and over 2 Softgels with water every 6 hrs children 4 to under 12 years consult a doctor children under 4 years do not use
| adults & children 12 years and over | 2 Softgels with water every 6 hrs |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide
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 relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Purpose
Information about the drug product’s indications for use.Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
Spl product data elements
Usually a list of ingredients in a drug product.AXIV NightTime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate PROPYLPARABEN D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE METHYLPARABEN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE AXIV
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.PRINCIPAL DISPLAY PANEL 24 Compare to VICKS ®NyQuil ® Cold & Flu LiquiCaps® active ingredients* NDC 82706-016-01 AXIV NightTime Cold & Flu Multi-Symptom Relief Pain Reliever Fever Reducer Cough Suppresant Antihistamine Nighttime Relief Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr 24 Softgels** **Liquid-filled capsules Night Time softgel 24
PACKAGE LABEL PRINCIPAL DISPLAY PANEL 100 Compare to VICKS ®NyQuil ® Cold & Flu LiquiCaps® active ingredients* NDC 82706-016-03 AXIV NightTime Cold & Flu Multi-Symptom Relief Pain Reliever Fever Reducer Cough Suppresant Antihistamine Nighttime Relief Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr 100 Softgels** **Liquid-filled capsules AXIV Night Time
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.Drug Facts
Distributed by: VIVUNT PHARMA LLC 8950 SW 74th. Court. Suite 1901 Miami, Florida, 33156-3178 Made in India www.vivunt.live
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 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 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 taking sedatives or tranquilizers
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. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleep
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 the reach of children Keep out of reach of children.
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.
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 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 20° - 25 °C (68 °- 77 °F) Read all product information before using Tamper Evident: Do not use if the foil printed on the blister is torn or ripped. Tamper Evident: Do not use if carton or pouch is open
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 8 Softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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, lasts 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 to make a child sleep 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 enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers 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. Keep out of the reach of children Keep out of reach of children. If pregnant or breast-feeding ask a health professional before use. Overdose warning 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 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