NDC 55910-617 Severe Cold And Cough Night Time

Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl

NDC Product Code 55910-617

NDC 55910-617-08

Package Description: 245 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Severe Cold And Cough Night Time with NDC 55910-617 is a a human over the counter drug product labeled by Dolgencorp, Inc. (dollar General & Rexall). The generic name of Severe Cold And Cough Night Time is acetaminophen, diphenhydramine hcl, phenylephrine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Dolgencorp, Inc. (dollar General & Rexall)

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Severe Cold And Cough Night Time Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 650 mg/30mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/30mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MALTITOL (UNII: D65DG142WK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dolgencorp, Inc. (dollar General & Rexall)
Labeler Code: 55910
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-30-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
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

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
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

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.

Severe Cold And Cough Night Time Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each 30 Ml)

Acetaminophen 650 mg Diphenhydramine HCl 25 mgPhenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducerAntihistamine/Cough suppressantNasal decongestant

Uses

  • Temporarily relievesminor aches and painssneezingheadacheminor sore throat
  • Painitchy, watery eyes
  • Nasal and sinus congestionrunny nosecough due to minor throat and bronchial irritation itchy nose or throattemporarily reduces fever

Warnings

  • Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:skin reddeningblistersrash Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this productSore 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

  • To make a child sleepy
  • 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 product containing diphenhydramine, even one used on skinwith any other product 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 heart diseasethyroid diseasehigh blood pressurediabetes
  • Cough accompanied by excessive phlegm (mucus)trouble urinating due to an enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitispersistent 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 warfarinsedatives or tranquilizers

When Using This Product

  • Do not use more than directed (see overdose warning)avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • Redness or swelling is present nervousness, dizziness, or sleeplessness occurspain, cough or nasal congestion gets worse or lasts more than 7 days
  • New symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with a 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) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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-hour periodmeasure only with dosing cup provided. Do not use any other dosing devicemL=milliliterkeep dosing cup with productadults and children 12 years and over30 mL every 4 hourschildren under 12 years of age; do not use

Other Information

  • Each 30 mL contains: potassium 10 mgeach 30 mL contains: sodium 14 mgstore at 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

Acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Product Label

Dollar General Night Time Severe Cold and Cough

* Please review the disclaimer below.