DS Never Cold S

Manufacturer
DongSung Pharm Co., Ltd. | Dong Sung World Wide USA, Inc.
Effective date
2020-12-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:02:49

Label at a glance#

ProductDS Never Cold S
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Liver 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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questons or Comments?

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Questions or comments? Call 1-562-802-0131 or Visit www.ds eshopusa.com

SPL UNCLASSIFIED SECTION

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

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Multi Symptom

COLD/FLU Relief

(Non-Drowsy)

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain reliever/fever reducer, Cough suppressant, Nasal decongestant

Cough, Sore Throat, Nasal Congestion, Fever, Headache

10 capsules

Carton ImageCarton Image

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42361-06342361-063-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c5dd69d7-09b1-e160-e053-2995a90a4db289bbf6d9-591e-f7ab-e053-2995a90a42e12021-06-28WarningsExact identifier
spl set id: 89bbf6d9-591e-f7ab-e053-2995a90a42e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.