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Axiv daytime - nighttime 48 softgels - Medication Information

Product NDC Code 82706-017
Drug Name

Axiv daytime - nighttime 48 softgels

Type Brand
Dosage Form KIT
RxCUI drug identifier 1094549,
1867684,
2676954
Application Number M012
Labeler Name VIVUNT PHARMA LLC
Packages
Package NDC Code Description
82706-017-01 1 kit in 1 package (82706-017-01) * 8 capsule, liquid filled in 1 blister pack * 8 capsule, liquid filled in 1 blister pack
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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 Dextrometrophan HBr 10 mg Cough Suppressant 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
Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain Reliever-fever reducer
Dextrometrophan HBr 10 mgCough Suppressant
Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

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 and children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years do not use Directions Take only as directed (see overdose warning): Do not take more than 8 softgels in 24 hours. adults and children 12 years and over 2 softgels with water every 6 hours children 4 to under 12 years consult a doctor children under 4 years do not use
adults and children 12 years and over2 softgels with water every 4 hours
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use
adults and children 12 years and over2 softgels with water every 6 hours
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide 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 and bronchial irritation sore throat headache minor aches and pains fever 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 Dextrometrophan HBr 10 mg Cough Suppressant 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
Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain Reliever-fever reducer
Dextrometrophan HBr 10 mgCough Suppressant
Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
AXIV DayTime - NightTime 48 Softgels Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate AXIV DayTime Acetaminophen, Dextromethorphan Hydrobromide PROPYLPARABEN METHYLPARABEN WATER GELATIN GLYCERIN TITANIUM DIOXIDE POVIDONE K30 POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID FD&C RED NO. 40 SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN AXIV AXIV NightTime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate PROPYLPARABEN METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL GELATIN FD&C BLUE NO. 1 POVIDONE K30 WATER TITANIUM DIOXIDE GLYCERIN D&C YELLOW NO. 10 SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE AXIV AXIV DayTime - NightTime 72 Softgels Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate AXIV DayTime Acetaminophen, Dextromethorphan Hydrobromide PROPYLPARABEN METHYLPARABEN WATER GELATIN GLYCERIN TITANIUM DIOXIDE POVIDONE K30 POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID FD&C RED NO. 40 SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN AXIV AXIV NightTime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate SORBITOL PROPYLPARABEN METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL GELATIN FD&C BLUE NO. 1 POVIDONE K30 WATER TITANIUM DIOXIDE GLYCERIN D&C YELLOW NO. 10 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN 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 - 48 Caps Day&Night Compare to Vicks® DayQuil ® & NyQuil ® Cold&Flu LiquiCaps® active ingredients* NDC 82706-017-01 AXIV DayTime Pain Reliever Fever Reducer Cough Suppressant Acetaminophen, Dextromethorphan HBr 32 SOFTGELS** **Liquid-filled capsules NightTime Pain Reliever Fever Reducer Cough Suppressant Antihistamine Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate 16 SOFTGELS** **Liquid-filled capsules *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ® Cold&Flu LiquiCaps®. ADN481 PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night Compare to Vicks® DayQuil ® & NyQuil ® Cold&Flu LiquiCaps® active ingredients* NDC 82706-018-01 AXIV DayTime Pain Reliever Fever Reducer Cough Suppressant Acetaminophen, Dextromethorphan HBr 48 SOFTGELS** **Liquid-filled capsules NightTime Pain Reliever Fever Reducer Cough Suppressant Antihistamine Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate 24 SOFTGELS** **Liquid-filled capsules *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ® Cold&Flu LiquiCaps®. ADN721

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.
Day Time Drug Facts Night Time 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 cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema 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. 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 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 reach of children Keep out of reach of children. Keep out of 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 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 exceed recommended dose 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 feeding
If 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 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 Other information Store at 20° - 25 °C (68 °- 77 °F) Read all product information before using Tamper evident: Do not use if carton is open or blister unit is broken.

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 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 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 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 Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough 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 exceed recommended dose 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 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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Allergy Alert 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. Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels 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 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 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. Allergy Alert 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.

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