L-Oral COLD & FLU RELIEF SYRUP
L-Oral COLD AND FLU RELIEF Syrup by
Drug Labeling and Warnings
L-Oral COLD AND FLU RELIEF 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 SYRUP- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride 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.
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L-Oral COLD & FLU RELIEF SYRUP
ACTIVE INGREDIENT (IN EACH 5 ML)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
USES
Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat and bronchial irritation Sore throat Headache Minor aches and pains Fever
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if Adult takes more than 4,000 mg of acetaminophen in 24 hours Child takes more than 5 doses in 24 hours Taken with other drugs containing acetaminophen Adult has 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 Heart disease Thyroid disease Diabetes High blood pressure Trouble urinating due to an enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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 a doctor if You get nervous, dizzy or sleepless Pain, nasal congestion or cough gets worse or lasts 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, ask a health professional before use.
DIRECTIONS
Take only as directed - see Overdose warning Only use the dose cup provided Do not exceed 4 doses per 24 hrs
| Adults & children 12 yrs & over | 30 mL every 4 hrs |
| Children 6 to under 12 yrs | 15 mL every 4 hrs |
| Children 4 to under 6 yrs | Ask a doctor |
| Children under 4 yrs | Do not use |
INACTIVE INGREDIENTS
Butylated hydroxyanisole, Edetate disodium, FD&C yellow no. 6, Flavor, Glycerin, Menthol, Monobasic sodium phosphate, Polyethylene glycol, Propylene glycol, Purified water, Saccharin sodium, Sucrose, Xanthan gum
| L-ORAL COLD AND FLU RELIEF SYRUP
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride syrup |
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| Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED | 860186917 | manufacture(73921-027) | |
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