DS NEVER COLD S- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

DS Never Cold S by

Drug Labeling and Warnings

DS Never Cold S by is a Otc medication manufactured, distributed, or labeled by DongSung Pharm Co., Ltd., Dong Sung World Wide USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Questons or Comments?

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

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

INGREDIENTS AND APPEARANCE

DS NEVER COLD S 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42361-063
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
POVIDONE K25 (UNII: K0KQV10C35)

Product Characteristics
Color	brown (Cacao Color)	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42361-063-01	1 in 1 CARTON	05/25/2019
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/25/2019

Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661)

Registrant - Dong Sung World Wide USA, Inc. (784969219)

Establishment
Name	Address	ID/FEI	Business Operations
Dong Sung Bio Pharm. Co., Ltd.		687811661	label(42361-063)