AXIV NightTime ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE VIVUNT PHARMA LLC FDA Approved Uses Temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Drug Facts

Composition & Profile

Active Ingredients
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
Inactive Ingredients
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
Strengths
325 mg 15 mg 6.25 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Cough Due To Minor Throat Bronchial Irritation Sore Throat Headache Minor Aches Pains Fever Runny Nose Sneezing
Pill Appearance
Shape: oval Color: green Imprint: AXIV

Identifiers & Packaging

Container Type UNKNOWN
UPC
0850047780591 0850047780379 0850047780416
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

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 24; 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 100 AXIV Night Time; Principal display panel 50 softgels Compare to VICKS ®NyQuil ® Cold & Flu LiquiCaps® active ingredients* NDC 82706-016-04 AXIV NightTime Cold & Flu Multi-Symptom Relief Pain Reliever Fever Reducer Cough Suppresant Antihistamine Nighttime Relief Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr 50 Softgels** **Liquid-filled capsules 50 ECO

Package Descriptions
  • 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 24
  • 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 100 AXIV Night Time
  • Principal display panel 50 softgels Compare to VICKS ®NyQuil ® Cold & Flu LiquiCaps® active ingredients* NDC 82706-016-04 AXIV NightTime Cold & Flu Multi-Symptom Relief Pain Reliever Fever Reducer Cough Suppresant Antihistamine Nighttime Relief Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr 50 Softgels** **Liquid-filled capsules 50 ECO

Overview

Uses Temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Indications & Usage

Uses Temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Dosage & Administration

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

Warnings & Precautions
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
Purpose

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

Do Not Use

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

When Using

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 & Ask a Doctor

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 the reach of children Keep out of reach of children.

Storage & Handling

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 Tamper Evident: Do not use if carton or blister is open.


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