Other
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
Axiv Daytime - Nighttime 48 Softgels Kit
FDA Label NDC 82706-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axiv Daytime - Nighttime 48 Softgels (NDC 82706-017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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 |
Uses
Temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
Temporarily relieves common cold/flu symptoms:
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
- 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
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy Alert
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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
- 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
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- 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 the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
do not exceed recommended dose
- 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.
- 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
These could be signs of a serious condition.
Keep Out Of Reach Of Children
Keep out of reach of children.
Keep out of reach of children.
If Pregnant Or Breast-Feeding
ask a health professional before use.
ask a health professional before use.
Overdose Warning
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
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.
Directions
- Take only as directed (see overdose warning):
- Do not take more than 8 softgels in 24 hours.
- 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 |
| 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 |
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
- 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.
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
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
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
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Antihistamine
Acetaminophen, Dextromethorphan HBr
32 SOFTGELS** **Liquid-filled capsules
NightTime
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®.
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
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Antihistamine
Acetaminophen, Dextromethorphan HBr
48 SOFTGELS** **Liquid-filled capsules
NightTime
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®.
* Please review the disclaimer below.
