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Drug Facts
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida, 33156-3178
Made in India
www.vivunt.live
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axiv Nighttime (NDC 82706-016). 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, warnings, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida, 33156-3178
Made in India
www.vivunt.live
| 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 |
Temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
These could be signs of a serious condition.
Keep out of reach of children.
ask a health professional before use.
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
| 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 |
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
Compare to VICKS ®NyQuil ®
Cold & Flu LiquiCaps®
active ingredients*
NDC 82706-016-01
AXIV NightTime Cold & Flu
Multi-Symptom Relief
Nighttime Relief
Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr
24 LiquiCaps** **Liquid-filled capsules
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.