42361-061 Drug Facts
Drug Labeling and Warnings
Drug Details [pdf]
DS NEVER COLD S- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Dong Sung Pharm. Co., Ltd.
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
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.
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
| DS NEVER COLD S
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
 |
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Dong Sung Pharm. Co., Ltd. (687811661) |
| Registrant - Dong Sung World Wide USA, Inc. (784969219) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Dong Sung Pharm. Co., Ltd. | 687811661 | label(42361-061) | |