Indications and uses
Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever
AXIM DayTime - Night Time 72 Softgels
- Manufacturer
- VIVUNT PHARMA LLC
- Effective date
- 2025-10-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 01:41:35
Label at a glance#
ProductAXIM DayTime - Night Time 48 Softgels
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, 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 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
Storage and handling
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.
Label 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 |
| Phenylephrine HCl 5 mg | Nasal Decongestant |
Uses
Temporarily relieves common cold/flu symptoms:
- nasal congestion
- 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 4,000 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
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
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- 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
- you get nervous, dizzy or sleepless
- 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
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 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 |
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
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 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.
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
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 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 |
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
Product of India
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida. Z,C. 33156-3178
PRINCIPAL DISPLAY PANEL - 48 Caps Day&Night
Compare to Vicks® DayQuil ® & NyQuil ®
Cold&Flu LiquiCaps®
active ingredients*
NDC 82706-003-01
Day Time
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Nasal Decongestant
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
32 SOFTGELS** **Liquid-filled capsules
Night Time
- 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 82706-004-01
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®.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 10 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 10 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 10 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 10 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 10 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 10 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 10 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 10 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 10 |
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 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82706-003-01 | 2025-08-20 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
| 82706-003-01 | 2025-08-20 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
| 82706-004-01 | 2025-08-20 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
| 82706-004-01 | 2025-08-20 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
| 82706-003-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
| 82706-003-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
| 82706-004-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
| 82706-004-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a177-d83d-e063-dadaa90ab31f | AXIM DayTime & Night Time |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82706-003-01 | AXIM DayTime - Night Time 48 Softgels | 1 in 1 PACKAGE | KIT | 1 | 10 | |
| 82706-004-01 | AXIM DayTime - Night Time 72 Softgels | 1 in 1 PACKAGE | KIT | 1 | 10 |
Products#
Every source-derived product name is available through these pages.
- AXIM DayTime - Night Time 48 Softgels
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
- AXIM DayTime
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- 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
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- SORBITOL
- AXIM Night Time
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- FD&C BLUE NO. 1
- D&C YELLOW NO. 10
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- AXIM DayTime - Night Time 72 Softgels
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82706-003 | 82706-003-01 |
| 82706-001 | |
| 82706-002 | |
| 82706-004 | 82706-004-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 9 | 2025-08-20 | full-release | 2026-06-01 01:11:17 |
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 |
|---|---|---|---|---|---|---|
| AXIM DayTime - Night Time 72 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | de9eb2d5-ba51-4637-e053-2995a90a0451 | 2025-10-29 | Warnings | 82706-003-01 82706-004-01 82706-003 82706-004 82706000401 82706000301 4251d4a4-6904-fa3d-e063-6294a90ae93d de9eb2d5-ba51-4637-e053-2995a90a0451 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.