FDA Label for Axiv Nighttime
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- WARNINGS
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF THE REACH OF CHILDREN
- IF PREGNANT OR BREAST-FEEDING
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL 24
- PRINCIPAL DISPLAY PANEL 4 SOFTGELS
Axiv Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Vivunt Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida, 33156-3178
Made in India
www.vivunt.live
Otc - Purpose
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 & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
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
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 |
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
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
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 LiquiCaps** **Liquid-filled capsules
Principal Display Panel 4 Softgels
Compare to VICKS ® NyQuil ®
Cold & Flu LiquiCaps®
active ingredients*
NDC 82706-016-02
AXIV NightTime Cold & Flu
Multi-Symptom Relief
Nighttime Relief
Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr
4 LiquiCaps** **Liquid-filled capsules
* Please review the disclaimer below.