L-Oral COLD & FLU RELIEF- DS SYRUP
L-Oral COLD AND FLU RELIEF-DS Syrup by
Drug Labeling and Warnings
L-Oral COLD AND FLU RELIEF-DS Syrup by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
L-ORAL COLD AND FLU RELIEF-DS SYRUP- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate syrup
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
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.
----------
L-Oral COLD & FLU RELIEF- DS SYRUP
ACTIVE INGREDIENTS (IN EACH 30 ML)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
USES
Temporarily relieves common cold/flu symptoms: Cough due to minor throat and bronchial irritation Sore throat Headache Minor aches and pains Fever Runny nose and sneezing
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
More than 4,000 mg of acetaminophen in 24 hours With other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Skin reddening
Blisters
Rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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.
If you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
Liver disease
Glaucoma
Cough that occurs with too much phlegm (mucus)
A breathing problem such as emphysema or chronic bronchitis
Trouble urinating due to an enlarged prostate gland
Persistent or chronic cough as occurs with smoking, asthma, or emphysema
A sodium-restricted diet
Ask a doctor or pharmacist before use if you are
Taking sedatives or tranquilizers
Taking the blood thinning drug
When using this product
Excitability may occur, especially in children
Marked drowsiness may occur
Avoid alcoholic drinks
Be careful when driving a motor vehicle or operating machinery
Alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
Pain or cough gets worse or lasts more than 7 days
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, Ask a health professional before use.
DIRECTIONS
Take only as directed - see Overdose warning Use dose cup Do not exceed 4 doses per 24 hrs
| Adults & children 12 yrs & over | 30 mL every 6 hrs |
| Children 4 to under 12 yrs | Ask a doctor |
| Children under 4 yrs | Do not use |
INACTIVE INGREDIENTS
Alcohol, Anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, Flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Purified water, Saccharin sodium, Sodium citrate
| L-ORAL COLD AND FLU RELIEF-DS SYRUP
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate syrup |
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
| Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED | 860186917 | manufacture(73921-028) | |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.