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

AXIV NightTime by

Drug Labeling and Warnings

AXIV NightTime 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

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 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 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 the 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 & children 12 years and over: 2 Softgels with water every 6 hrs
• 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.
• Tamper Evident: Do not use if carton or pouch is open

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 24

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC: 82706-016-01

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppresant
Antihistamine
Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

24 Softgels** **Liquid-filled capsules

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 100

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC: 82706-016-03

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppresant
Antihistamine

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

100 Softgels** **Liquid-filled capsules

INGREDIENTS AND APPEARANCE

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

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

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

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN (UNII: A2I8C7HI9T)

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	NDC: 82706-016-01	3 in 1 CARTON	03/07/2024
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 82706-016-02	2 in 1 CARTON	03/07/2024	03/07/2024
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 82706-016-03	50 in 1 CARTON	07/05/2024
3		2 in 1 POUCH; 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	03/07/2024

Labeler - VIVUNT PHARMA LLC (045829437)