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Drug Facts
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, FL 33156-3178
Made in USA
www.vivunt.live
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axim Night Time - Liquid (NDC 82706-012). 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, FL 33156-3178
Made in USA
www.vivunt.live
| Active ingredients (in each 30 mL dose cup) | Purpose |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
Temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if:
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.
Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. 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 and children 12 years and over | 30 mL every 6 hours |
| children under 12 years | do not use |
Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Compare to VICKS ®NyQuil ®
Cold & Flu active ingredients*
NDC 82706-012-01
AXIM - NightTime
COLD&FLU
Multi-Symptom Relief
Nighttime Relief
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
12 FL OZ (355 mL)
*This product is not manufactured or distributed by The Procter &Gamble Company, owner of registered trademarks Vicks® NyQuil®
* Please review the disclaimer below.