NDC 0113-0656 Good Sense Daytime Non Drowsy Cold And Flu
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl Solution Oral
Product Information
What is NDC 0113-0656?
The NDC code 0113-0656 is assigned by the FDA to the product Good Sense Daytime Non Drowsy Cold And Flu which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Daytime Non Drowsy Cold And Flu is acetaminophen, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is solution and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0113-0656-34 237 ml in 1 bottle , 0113-0656-40 354 ml in 1 bottle . 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 Good Sense Daytime Non Drowsy Cold And Flu?
This product is used as Pain reliever/fever reducerCough suppressantNasal decongestant. •temporarily relieves common cold/flu symptoms:•nasal congestion•cough due to minor throat and bronchial irritation•sore throat•headache•minor aches and pains•fever
Product Characteristics
Color(s) | ORANGE (C48331 - CLEAR) |
Flavor(s) | MENTHOL (C73403 - WITH FRUIT) |
Product Details
What are Good Sense Daytime Non Drowsy Cold And Flu Active Ingredients?
- ACETAMINOPHEN 325 mg/15mL - 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 10 mg/15mL - 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.
- PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.
Good Sense Daytime Non Drowsy Cold And Flu Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
- PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ)
- PHENYLEPHRINE (UNII: 1WS297W6MV) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1113705 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
- RxCUI: 1113705 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
- RxCUI: 1113705 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
- RxCUI: 1113705 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
- RxCUI: 1113705 - APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
Good Sense Daytime Non Drowsy Cold And Flu Inactive Ingredients UNII Codes
- BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
- EDETATE DISODIUM (UNII: 7FLD91C86K)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- GLYCERIN (UNII: PDC6A3C0OX)
- MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
- SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
- SUCROSE (UNII: C151H8M554)
- XANTHAN GUM (UNII: TTV12P4NEE)
Pharmacologic Class(es)
- Adrenergic alpha1-Agonists - [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)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
* 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?Phenylephrine
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]
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.
Good Sense Daytime Non Drowsy 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 15 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
Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
• temporarily relieves common cold/flu symptoms:• nasal congestion• cough due to minor throat and bronchial irritation• sore throat• headache• minor aches and pains• fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours• child takes more than 5 doses in 24 hours• taken with other drugs containing acetaminophen• adult has 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.• 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
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to an enlarged prostate gland• cough that occurs with too much phlegm (mucus)• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not use more than directed
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)• 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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• only use the dose cup provided• do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 6 to under 12 yrs | 15 mL every 4 hrs |
children 4 to under 6 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
• each 15 mL contains: sodium 7 mg• store at 20-25°C (68-77°F)
Inactive Ingredients
butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Multi-Symptom Relief
See New Warnings
Non-Drowsy
Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant
DayTime
Cold & Flu
Acetaminophen
Phenylephrine HCl
Dextromethorphan HBr
Aches
Fever
Cough
Sore Throat
Nasal Congestion
Compare to active ingredients of Vicks® DayQuil® Cold & Flu
12 FL OZ (354 mL)
Alcohol Free
Powerful Non-Drowsy Relief
* Please review the disclaimer below.