AXIM Night Time - Liquid ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE VIVUNT PHARMA LLC FDA Approved Uses Temporarily relieves common cold/flu symptoms: sore throat minor aches & pains runny nose & sneezing headache fever cough due to minor throat & bronchial irritation
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine
Inactive Ingredients
Inactive ingredients Citric acid FD&C Blue #1 FD&C Red #40 flavor glycerin menthol propylene glycol purified water sodium benzoate sorbitol solution sucralose xanthan gum
Strengths
30 ml 650 mg 30 mg 12.5 mg
Quantities
355 ml
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Sore Throat Minor Aches Pains Runny Nose Sneezing Headache Fever Cough Due To Minor Throat Bronchial Irritation
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0850047780188
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

PRINCIPAL DISPLAY PANEL Compare to VICKS ® NyQuil ® Cold & Flu active ingredients* NDC 82706-012-01 AXIM - NightTime COLD&FLU Multi-Symptom Relief Pain Reliever Fever Reducer Cough Suppresant Antihistamine Nighttime Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate 12 FL OZ (355 mL) *This product is not manufactured or distributed by The Procter &Gamble Company, owner of registered trademarks Vicks® NyQuil® ANT Liq

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Compare to VICKS ® NyQuil ® Cold & Flu active ingredients* NDC 82706-012-01 AXIM - NightTime COLD&FLU Multi-Symptom Relief Pain Reliever Fever Reducer Cough Suppresant Antihistamine Nighttime Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate 12 FL OZ (355 mL) *This product is not manufactured or distributed by The Procter &Gamble Company, owner of registered trademarks Vicks® NyQuil® ANT Liq

Overview

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

Indications & Usage

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

Dosage & Administration

Directions take only as directed (see overdose warning) measure only with dosage cup provided and keep dosage cup with product mL = milliliter do not exceed 4 doses per 24 hours when using DayTime and NightTime products, limit total to 4 doses per 24 hours adults and children 12 years and over 30 mL every 6 hours children under 12 years do not use

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if: adults and children over 12 years of age take more than 4 doses (30 mL each) 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 sedatives or tranquilizers taking the blood thinning drug warfarin 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. These could be signs of a serious condition. Keep out of reach of children. If pregnant or breast-feeding ask a health professional before use. Overdose warning Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. 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 30 mL dose cup) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 12.5 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. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information Each 30 mL dose cup contains: sodium 10 mg Store at room temperature 15 - 30°C (59 - 89°F) and do not refrigerate Tamper evident: Do not use if shrink band is missing or broken


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