L-ORAL COLD AND FLU RELIEF-DS SYRUP- acetaminophen, dextromethorphan hydrobromide and 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.
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Pain reliever / Fever reducer
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
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.
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as or children even if you do not notice any signs or symptoms.
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|
• Each 30 mL contains: sodium 38 mg • Store at 20-25°C (68-77°F)
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
Call toll-free 1-800-572-6632, weekdays, 7:00 AM — 5:30 PM EST.
√ Cough Relief √ Aches
√ Fever √ Sore throat
√ Sneezing/Runny nose
Global Pharma Healthcare Pvt. Ltd.,
A-9, SIDCO Pharmaceutical Complex,
Alathur-603 110 — INDIA.
| L-ORAL COLD AND FLU RELIEF-DS SYRUP |
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate syrup
|Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)|
|GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED||860186917||manufacture (73921-028)|
Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.