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DS Never Cold S

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Dong Sung Pharm. Co., Ltd.
NDC Code: 42361-061

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

42361-061 Drug Facts

Drug Facts

Active Ingredient

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

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

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 polyethylene glycol 400, gelatin, sorbitol, water, povidone k-25, propylene glycol, caramel color

Questons or Comments?

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

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

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

DS NEVER COLD S 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42361-061
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
PROPYLENE GLYCOL 
CARAMEL 
POLYETHYLENE GLYCOL 400 
GELATIN 
POVIDONE K25 
Product Characteristics
Colorbrown (Caramel) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeNCS
Contains    
Packaging
#Item CodePackage Description
1NDC:42361-061-011 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/18/201705/31/2019
Labeler - Dong Sung Pharm. Co., Ltd. (687811661)
Registrant - Dong Sung World Wide USA, Inc. (784969219)
Establishment
NameAddressID/FEIOperations
Dong Sung Pharm. Co., Ltd.687811661label(42361-061)

 
Dong Sung Pharm. Co., Ltd.

Medically reviewed on Nov 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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