Indications and uses
Temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever
AXIV DayTime - NightTime 72 Softgels
- Manufacturer
- VIVUNT PHARMA LLC
- Effective date
- 2025-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:41:40
Label at a glance#
ProductAXIV DayTime - NightTime 48 Softgels
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Label structure17 sections
Dosage and administration
Take only as directed (see overdose warning): Do not take more than 8 softgels in 24 hours. adults and children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years do not use
Storage and handling
Store at 20° - 25 °C (68 °- 77 °F) Read all product information before using Tamper evident: Do not use if the foil printed on the blister is torn or ripped
Contacts and useful links#
Websitewww.vivunt.live
www.vivunt.live
www.vivunt.liveLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Day Time
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each softgel) | Purpose |
| Acetaminophen 325 mg | Pain Reliever-fever reducer |
| Dextrometrophan HBr 10 mg | Cough Suppressant |
Uses
Temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
- 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
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
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dose
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
Keep out of reach of children
Keep out of reach of children.
If pregnant or breast-feeding
ask a health professional before use.
Overdose warning
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Directions
- Take only as directed (see overdose warning):
- Do not take more than 8 softgels in 24 hours.
adults and children 12 years and over | 2 softgels with water every 4 hours |
children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
Other information
- Store at 20° - 25 °C (68 °- 77 °F)
- Read all product information before using
- Tamper evident: Do not use if the foil printed on the blister is torn or ripped
Inactive ingredients
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
SPL UNCLASSIFIED SECTION
Night Time
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE 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 |
Uses
Temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
- 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.
Keep out of reach of children
Keep out of reach of children.
If pregnant or breast-feeding
ask a health professional before use.
Overdose warning
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):
- Do not take more than 8 softgels in 24 hours.
| adults and children 12 years and over | 2 softgels with water every 6 hours |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
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 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
SPL UNCLASSIFIED SECTION
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida, 33156-3178
Made in India
PRINCIPAL DISPLAY PANEL - 48 Caps Day&Night
Compare to Vicks® DayQuil ® & NyQuil ®
Cold&Flu LiquiCaps®
active ingredients*
NDC 82706-017-01
AXIV
DayTime
- Pain Reliever
- Fever Reducer
- Cough Suppressant
Acetaminophen, Dextromethorphan HBr
32 SOFTGELS** **Liquid-filled capsules
NightTime
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Antihistamine
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
16 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®.
PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night
Compare to Vicks® DayQuil ® & NyQuil ®
Cold&Flu LiquiCaps®
active ingredients*
NDC 82706-018-01
AXIV
DayTime
- Pain Reliever
- Fever Reducer
- Cough Suppressant
Acetaminophen, Dextromethorphan HBr
48 SOFTGELS** **Liquid-filled capsules
NightTime
- 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®.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2676954 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 2 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 2 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 2 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 2 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 2 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 2 |
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 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850047780003 | GTIN-13: 0850047780003 EAN-13: 0850047780003 GTIN-12: 850047780003 UPC-A: 850047780003 GTIN storage (14 digits): 00850047780003 | Est Axiv DayNight Time x 72 caps_001-min-compressed.jpg |
| Barcode | EAN-13 | 0850047780577 | GTIN-13: 0850047780577 EAN-13: 0850047780577 GTIN-12: 850047780577 UPC-A: 850047780577 GTIN storage (14 digits): 00850047780577 | ETIQUETA COMPRIMIDA DAY NIGHT.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82706-017-01 | AXIV DayTime - NightTime 48 Softgels | 1 in 1 PACKAGE | KIT | 1 | 2 | |
| 82706-018-01 | AXIV DayTime - NightTime 72 Softgels | 1 in 1 PACKAGE | KIT | 1 | 2 |
Products#
Every source-derived product name is available through these pages.
- AXIV DayTime - NightTime 48 Softgels
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- AXIV DayTime
- Acetaminophen, Dextromethorphan Hydrobromide
- PROPYLPARABEN
- METHYLPARABEN
- WATER
- GELATIN
- GLYCERIN
- TITANIUM DIOXIDE
- POVIDONE K30
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- FD&C RED NO. 40
- SORBITOL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- AXIV NightTime
- FD&C BLUE NO. 1
- D&C YELLOW NO. 10
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- AXIV DayTime - NightTime 72 Softgels
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82706-017 | 82706-017-01 |
| 82706-015 | |
| 82706-016 | |
| 82706-018 | 82706-018-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2024-03-08 | full-release | 2026-06-01 00:09:36 |
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 NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 131f6314-c9a1-7af3-e063-6294a90abe6f | 2025-09-17 | Warnings | 82706-016 |
| AXIV DayTime - NightTime 48 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 1320e243-344f-98ed-e063-6294a90a0092 | 2025-09-17 | Warnings | 82706-018-01 82706-017-01 82706-018 82706-017 82706001701 82706001801 3f04c92d-9597-0656-e063-6294a90ab97d 1320e243-344f-98ed-e063-6294a90a0092 |
| AXIV DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 131b1f17-cd86-f9b3-e063-6294a90a3028 | 2025-02-12 | Warnings | 82706-015 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.