AXIM DayTime - Night Time 48 Softgels
AXIM DayTime & Night Time
de9eb2d5-ba51-4637-e053-2995a90a0451
HUMAN OTC DRUG LABEL
Aug 20, 2025
VIVUNT PHARMA LLC
DUNS: 045829437
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night
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, Dextromethorphan HBr, Phenylephrine HCl
48 SOFTGELS****Liquid-filled capsules
Night Time
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Antihistamine
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®.
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
SPL UNCLASSIFIED SECTION
Product of India
Distributed by:
VIVUNT PHARMA LLC
** 8950 SW 74th. Court. Suite 1901**
Miami, Florida. Z,C. 33156-3178
OTC - ACTIVE INGREDIENT SECTION
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 |
WARNINGS SECTION
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of acetaminophen in 24 hours.
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy Alert
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.
These could be signs of a serious condition.
Keep out of reach of children.
If pregnant or breast-feeding
ask a health professional before use.
Overdose warning
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
DOSAGE & ADMINISTRATION SECTION
Directions
- Take only as directed (see overdose warning):
- Do not take more than 8 softgels in 24 hours.
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 |
STORAGE AND HANDLING SECTION
Other information
- 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 INGREDIENT SECTION
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