NDC 30142-634 Night Time Cold And Flu
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate Liquid Oral
Product Information
What is NDC 30142-634?
The NDC code 30142-634 is assigned by the FDA to the product Night Time Cold And Flu which is a human over the counter drug product labeled by The Kroger Co.. The generic name of Night Time Cold And Flu is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 30142-634-12 355 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Night Time Cold And Flu?
This product is used as Pain reliever/fever reducerCough suppressantAntihistamine. Temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatfeverrunny nose and sneezingcough due to minor throat and bronchial irritation
Product Details
What are Night Time Cold And Flu Active Ingredients?
- ACETAMINOPHEN 650 mg/30mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
- DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
- DOXYLAMINE SUCCINATE 12.5 mg/30mL
Night Time Cold And Flu Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
- DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2)
- DOXYLAMINE (UNII: 95QB77JKPL) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
- RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
- RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
- RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
Night Time Cold And Flu Inactive Ingredients UNII Codes
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
- ALCOHOL (UNII: 3K9958V90M)
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
- TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
Pharmacologic Class(es)
- Antihistamine - [EPC] (Established Pharmacologic Class)
- Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
Patient Education
Acetaminophen
Acetaminophen is pronounced as (a set a mee' noe fen)
Why is acetaminophen medication prescribed?Dextromethorphan
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?Doxylamine
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]
* Please review the disclaimer below.
Night Time Cold And Flu Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
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
- the blood thinning drug warfarin
When Using This Product
- 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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- do not take more than directed (see overdose warning)
- do not take more than 4 doses in any 24-hours period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years of age: do not use
- When using other Day Time or Night Time products, carefully read each label to insure correct dosing
Other Information
- each 30 mL contains; potassium 5 mg
- each 30 mL contains: sodium 19 mg
- store between 20-25°C (68-77F). Do not refrigerate.
Inactive Ingredients
acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions Or Comments?
Call 1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredients of VICKS® NYQUIL® COLD & FLU *See back panel
Cold & Flu
NightTime
Multi-Symptom Relief
Acetaminophen
Dextromethorphan HBr
Doxylamine succinate
Pain Reliever
Fever Reducer
Cough Suppressant
Antihistamine
For Ages 12 Years & Older
ALCOHOL 10%
FL OZ (mL)
*Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company, Cincinnati, OH 45202.The Procter & Gamble Company is not affiliate with The Kroger Co. or this product.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY THE KROGER CO.
CINCINNATI,OHIO 45202
Product Label
KROGER Nighttime Cold & Flu Relief
* Please review the disclaimer below.