NDC 11673-460 Nighttime Cold And Flu Maximum Strength
Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci Liquid Oral
Product Information
What is NDC 11673-460?
The NDC code 11673-460 is assigned by the FDA to the product Nighttime Cold And Flu Maximum Strength which is a human over the counter drug product labeled by Target Corporation. The generic name of Nighttime Cold And Flu Maximum Strength is acetaminophen, diphenhydramine hci, phenylephrine hci. 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 11673-460-06 177 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 Nighttime Cold And Flu Maximum Strength?
This product is used as Pain reliever/fever reducerAntihistamine / cough suppressantNasal decongestant. Temporarily relieves these common cold and flu symptomscoughnasal congestionminor ache and painssore throatheadacherunny nosesneezingtemporarily reduces fevercontrols cough to help you get to sleep
Product Details
What are Nighttime Cold And Flu Maximum Strength Active Ingredients?
- ACETAMINOPHEN 650 mg/20mL - 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.
- DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/20mL - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
- PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.
Nighttime Cold And Flu Maximum Strength Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
- DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
- DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)
- PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ)
- PHENYLEPHRINE (UNII: 1WS297W6MV) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1375932 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
- RxCUI: 1375932 - acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
- RxCUI: 1375932 - acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
- RxCUI: 1375932 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
- RxCUI: 1375932 - APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
Nighttime Cold And Flu Maximum Strength Inactive Ingredients UNII Codes
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- GLYCERIN (UNII: PDC6A3C0OX)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- SORBITOL (UNII: 506T60A25R)
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- PROPYL GALLATE (UNII: 8D4SNN7V92)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SODIUM CITRATE (UNII: 1Q73Q2JULR)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- XANTHAN GUM (UNII: TTV12P4NEE)
- EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
Pharmacologic Class(es)
* Please review the disclaimer below.
Patient Education
Acetaminophen
Acetaminophen is pronounced as (a set a mee' noe fen)
Why is acetaminophen medication prescribed?Diphenhydramine
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]
Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?Phenylephrine
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]
* Please review the disclaimer below.
Nighttime Cold And Flu Maximum Strength 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 20 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
- 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 20 Ml)
Acetaminophen 650 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 10 mg
Purpose
Pain reliever/fever reducer
Antihistamine / cough suppressant
Nasal decongestant
Uses
- temporarily relieves these common cold and flu symptoms
- cough
- nasal congestion
- minor ache and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen 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 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.
- with any other drug containing diphenhydramine even one used on the skin
- 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.
- for children under 12 years of age
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
- you are taking the blood thinning drug warfarin
- you are 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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 fever, 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) can 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 6 doses in any 24 hours period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
- dose as follows or as directed by a doctor
- adults and children 12 years and older :
- 20 mL every 4 hours while symptoms last
- children under 12 years of age do not use
Other Information
- each 20 mL contains: sodium 12 mg
- store between 20-25°C (68-77F). Do not refrigerate
Inactive Ingredients
citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Call 1-800-910-6874
Principal Display Panel
Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® NightTime Cold & Flu*
maximum strength
Nighttime
cold and Flu
acetaminophen
( pain reliever / fever reducer)
diphenhydramine HCI
(antihistamine / cough suppressant)
phenylephrine HCI
(nasal decongestant)
relieves aches, fever and sore throat
controls cough
relieves nasal congestion
relieves runny nose & sneezing
AGES 12 + YEARS
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex®Fast-Max® Night Time Cold & Flu.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Dist. by Target Corp.
Mpls., MN 55403
Product of U.S.A.
Product Label
TARGET NightTime Cold and Flu Maximum Strength
* Please review the disclaimer below.