NDC 42361-063 Ds Never Cold S

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl

NDC Product Code 42361-063

NDC Code: 42361-063

Proprietary Name: Ds Never Cold S What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BROWN (C48332 - CACAO COLOR)
Shape: CAPSULE (C48336)
Size(s):
25 MM
Score: 1

NDC Code Structure

  • 42361 - Dong Sung Bio Pharm. Co., Ltd.
    • 42361-063 - Ds Never Cold S

NDC 42361-063-01

Package Description: 1 BLISTER PACK in 1 CARTON > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Ds Never Cold S with NDC 42361-063 is a a human over the counter drug product labeled by Dong Sung Bio Pharm. Co., Ltd.. The generic name of Ds Never Cold S is acetaminophen, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Dong Sung Bio Pharm. Co., Ltd.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Ds Never Cold S 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 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1

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.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • GELATIN (UNII: 2G86QN327L)
  • POVIDONE K25 (UNII: K0KQV10C35)

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: Dong Sung Bio Pharm. Co., Ltd.
Labeler Code: 42361
FDA Application Number: part343 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-25-2019 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: 12-31-2020 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.

Ds Never Cold S 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

Other

Drug Facts

TAMPER EVIDENT: Do not use if package is opened or blister unit is torn, broken or shows any signs of tampering.Distributed by Dong Sung World Wide USA, Inc. MADE IN KOREA

Purpose

Purpose Pain reliever/fever reducer, Cough suppressant, Nasal decongestant

Uses

IMPORTANT : READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS BOX FOR IMFORMATION.Uses temporarily relieves common cold/flu symptoms:
▪ cough due to minor throat & bronchial irritation ▪ sore throat ▪ nasal congestion ▪ minor aches & pains ▪ fever ▪ headache

Warnings

WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 4 doses (8 capsules) in 24 hours, which is the maximum daily amount for this product ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

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.

Ask A Doctor Before Use If You Have

Ask a doctor before use if you have▪ liver disease ▪ heart disease ▪ thyroid disease ▪ diabetes ▪ high blood pressure ▪ trouble urinating due to enlarged prostate gland ▪ cough that occurs with too much phlegm (mucus) ▪ persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

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 Doctor If

Stop use and ask doctor if▪ you get nervous, dizzy or sleepless symptoms get worse or last 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

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

Keep out of reach of children.

Overdose Warning

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Directions

Directions ▪ take only as directed - see Overdose warning
▪ do not exceed 4 doses per 24 hrs▪ Adults and children 12 yrs ̃over: 2 capsules with water every 4 hours▪ Children 4 to 12 yrs: ask a doctor▪ Children under 4 yrs: do not use

Other Information

Other Information store at room temperature away from direct sunlight or excessive heat

Inactive Ingredients

Inactive Ingredients Cacao Color, Gelatin, Polyethylene Glycol 400, Povidone, Propylene Glycol, Sorbitol, Water

Principle Display Panel

Multi SymptomCOLD/FLU Relief(Non-Drowsy)Acetaminophen, Dextromethorphan HBr, Phenylephrine HClPain reliever/fever reducer, Cough suppressant, Nasal decongestantCough, Sore Throat, Nasal Congestion, Fever, Headache10 capsules

* Please review the disclaimer below.

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