AXIV NightTime (axiv nighttime (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) capsule, liquid filled) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

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
• bulers
• 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 buler 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

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 LiquiCaps** **Liquid-filled capsules

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