AXIM DAYTIME - NIGHT TIME 48 SOFTGELS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride 
AXIM DAYTIME - NIGHT TIME 72 SOFTGELS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride 
VIVUNT PHARMA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

AXIM DayTime & Night Time

Day Time

Drug Facts

Active ingredients (in each softgel)Purpose
Acetaminophen 325 mg

Pain Reliever-fever reducer

Dextrometrophan HBr 10 mgCough Suppressant
Phenylephrine HCl 5 mgNasal Decongestant

Uses

Temporarily relieves common cold/flu symptoms:

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


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

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 yearsdo not use

Other information

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

Night Time

Drug Facts

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:

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

Directions

adults and children over 12 years2 softgels with water every 6 hours
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use

Other information

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

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

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

32 SOFTGELS** **Liquid-filled capsules


Night Time

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®.

AXIM DayTime Night Time 48 caps

PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-004-01

Day Time

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

48 SOFTGELS** **Liquid-filled capsules


Night Time

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®.

AXIM DayTime Night Time 72 caps

AXIM DAYTIME - NIGHT TIME 48 SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-003
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82706-003-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package05/09/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32 
Part 22 BLISTER PACK 16 
Part 1 of 2
AXIM DAYTIME 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:82706-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE K30 (UNII: U725QWY32X)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize22mm
FlavorImprint Code axim
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2022
Part 2 of 2
AXIM NIGHT TIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Item Code (Source)NDC:82706-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize22mm
FlavorImprint Code axim
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2022
AXIM DAYTIME - NIGHT TIME 72 SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-004
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82706-004-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package05/09/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 BLISTER PACK 48 
Part 23 BLISTER PACK 24 
Part 1 of 2
AXIM DAYTIME 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:82706-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE K30 (UNII: U725QWY32X)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize22mm
FlavorImprint Code axim
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2022
Part 2 of 2
AXIM NIGHT TIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Item Code (Source)NDC:82706-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize22mm
FlavorImprint Code axim
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2022
Labeler - VIVUNT PHARMA LLC (045829437)

Revised: 2/2023
Document Id: f435d670-87fe-f226-e053-2a95a90ac0ee
Set id: de9eb2d5-ba51-4637-e053-2995a90a0451
Version: 8
Effective Time: 20230208
 
VIVUNT PHARMA LLC