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

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AXIV NightTime Cold & Flu

Drug Facts

Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Uses

Temporarily relieves common cold/flu symptoms:

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

adults & children 12 years and over2 Softgels with water every 6 hrs
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

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

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

24 LiquiCaps** **Liquid-filled capsules

AXIV1NIGHT

PRINCIPAL DISPLAY PANEL 4 SOFTGELS

Compare to VICKS ® NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC 82706-016-02

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

4 LiquiCaps** **Liquid-filled capsules

AXIV1NIGHTC

AXIV NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScoreno score
ShapeOVALSize22mm
FlavorImprint Code AXIV
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82706-016-013 in 1 CARTON03/07/2024
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:82706-016-022 in 1 CARTON03/07/2024
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/07/2024
Labeler - VIVUNT PHARMA LLC (045829437)

Revised: 3/2024
Document Id: 131f6314-c9a0-7af3-e063-6294a90abe6f
Set id: 131f6314-c9a1-7af3-e063-6294a90abe6f
Version: 1
Effective Time: 20240307
 
VIVUNT PHARMA LLC