Other
Day Time
Drug Facts
Night Time
Drug Facts
Product of India
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida. Z,C. 33156-3178
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axim Daytime - Night Time 48 Softgels (NDC 82706-003). 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.
Day Time
Drug Facts
Night Time
Drug Facts
Product of India
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida. Z,C. 33156-3178
| Active ingredients (in each softgel) | Purpose |
| Acetaminophen 325 mg | Pain Reliever-fever reducer |
| Dextrometrophan HBr 10 mg | Cough Suppressant |
| Phenylephrine HCl 5 mg | Nasal Decongestant |
| 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:
temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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: 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.
taking the blood thinning drug warfarin.
do not exceed recommended dose
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.
ask a health professional before use.
ask a health professional before use.
In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
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 over 12 years | 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 over 12 years | 2 Softgels with water every 6 hours |
| Children 4 to under 12 years | consult a doctor |
| Children under 4 years | do not use |
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
Compare to Vicks ® DayQuil ® & NyQuil ®
Cold&Flu LiquiCaps®
active ingredients*
NDC 82706-003-01
Day Time
Acetaminophen , Phenylephrine HCl, Dextromethorphan HBr
32 SOFTGELS** **Liquid-filled capsules
Night Time
Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr
16 SOFTGELS** **Liquid-filled capsules
Compare to Vicks ® DayQuil ® & NyQuil ®
Cold&Flu LiquiCaps®
active ingredients*
NDC 82706-004-01
Day Time
Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant
Acetaminophen , Phenylephrine HCl, Dextromethorphan HBr
48 SOFTGELS** **Liquid-filled capsules
Night Time
Headache, Fever, Sore Throat, Minor Aches & Pains
Sneezing, Runny Nose
Cough
Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr
24 SOFTGELS** **Liquid-filled capsules
* Please review the disclaimer below.