AXIV DAYTIME - NIGHTTIME 48 SOFTGELS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate kit AXIV DAYTIME - NIGHTTIME 72 SOFTGELS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate kit

AXIV DayTime - NightTime 72 Softgels by

Drug Labeling and Warnings

AXIV DayTime - NightTime 72 Softgels by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Day Time

Drug Facts

ACTIVE INGREDIENT

• 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

ACTIVE INGREDIENT

• 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

www.vivunt.live

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®.

INGREDIENTS AND APPEARANCE

AXIV DAYTIME - NIGHTTIME 48 SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-017

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-017-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	03/08/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	32
Part 2	2 BLISTER PACK	16

Part 1 of 2

AXIV DAYTIME 
acetaminophen, dextromethorphan hydrobromide capsule, liquid filled

Product Information
Item Code (Source)	NDC: 82706-015
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AXIV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/08/2024

Part 2 of 2

AXIV NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Item Code (Source)	NDC: 82706-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AXIV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/08/2024

AXIV DAYTIME - NIGHTTIME 72 SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-018

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-018-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	03/08/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 BLISTER PACK	48
Part 2	3 BLISTER PACK	24

Part 1 of 2

AXIV DAYTIME 
acetaminophen, dextromethorphan hydrobromide capsule, liquid filled

Product Information
Item Code (Source)	NDC: 82706-015
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AXIV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/08/2024

Part 2 of 2

AXIV NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Item Code (Source)	NDC: 82706-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AXIV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/08/2024

Labeler - VIVUNT PHARMA LLC (045829437)