Indications and uses
Temporarily relieves common cold/flu symptoms: sore throat minor aches & pains runny nose & sneezing headache fever cough due to minor throat & bronchial irritation
AXIV Night Time - Liquid
- Manufacturer
- VIVUNT PHARMA LLC
- Effective date
- 2025-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:59
Label at a glance#
ProductAXIV Night Time - Liquid
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections
Dosage and administration
take only as directed (see overdose warning) measure only with dosage cup provided and keep dosage cup with product mL = milliliter do not exceed 4 doses per 24 hours when using DayTime and NightTime products, limit total to 4 doses per 24 hours adults and children 12 years and over 30 mL every 6 hours children under 12 years do not use
Storage and handling
Each 30 mL dose cup contains: sodium 10 mg Store at room temperature 15 - 30°C (59 - 89°F) and do not refrigerate Tamper evident: Do not use if shrink band is missing or broken
Contacts and useful links#
Websitewww.vivunt.live
www.vivunt.live
www.vivunt.liveLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| 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 |
Uses
Temporarily relieves common cold/flu symptoms:
- sore throat
- minor aches & pains
- runny nose & sneezing
- headache
- fever
- cough due to minor throat & bronchial irritation
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if:
- adults and children over 12 years of age take more than 4 doses (30 mL each) 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 sedatives or tranquilizers
- taking the blood thinning drug warfarin
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If pregnant or breast-feeding
ask a health professional before use.
Overdose warning
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
Directions
- take only as directed (see overdose warning)
- measure only with dosage cup provided and keep dosage cup with product
- mL = milliliter
- do not exceed 4 doses per 24 hours
- when using DayTime and NightTime products, limit total to 4 doses per 24 hours
| adults and children 12 years and over | 30 mL every 6 hours |
| children under 12 years | do not use |
Other information
- Each 30 mL dose cup contains: sodium 10 mg
- Store at room temperature 15 - 30°C (59 - 89°F) and do not refrigerate
- Tamper evident: Do not use if shrink band is missing or broken
Inactive ingredients
Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
SPL UNCLASSIFIED SECTION
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, FL 33156-3178
Made in USA
PRINCIPAL DISPLAY PANEL
Compare to VICKS ®NyQuil ®
Cold & Flu active ingredients*
NDC 82706-023-01
AXIV - NightTime
COLD&FLU
Multi-Symptom Relief
- Pain Reliever
- Fever Reducer
- Cough Suppresant
- Antihistamine
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®
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 4 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 4 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 4 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 4 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82706-023-01 | AXIV Night Time - Liquid | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 4 |
Products#
Every source-derived product name is available through these pages.
- AXIV Night Time - Liquid
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- CITRIC ACID MONOHYDRATE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- MENTHOL, UNSPECIFIED FORM
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL SOLUTION
- SUCRALOSE
- XANTHAN GUM
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82706-023 | 82706-023-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AXIV Night Time - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 186f8519-655d-bd21-e063-6294a90a16a8 | 2025-09-17 | Warnings | 82706-023-01 82706-023 82706002301 3f031dfb-be56-5a44-e063-6394a90aeec5 186f8519-655d-bd21-e063-6294a90a16a8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.