TOPCARE COUGH COLD AND FLU SIMPLE RELIEF
Dosage form: liquid
Ingredients: CHOLINE SALICYLATE 870mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 30mL, GUAIFENESIN 200mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: TOPCO ASSOCIATES LLC
NDC Code: 36800-777
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.
TOPCARE COUGH COLD & FLU SIMPLE RELIEF
(choline salicylate, dextromethorphan hbr, guaifenesin, phenylephrine hcl), solution
Topco Associates LLC
Topco Associates LLC. Cough Cold & Flu Simple Relief Drug Facts
Choline Salicylate (NSAID)* 870 mg
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
temporarily relieves these common cold and flu symptoms:
▪ nasal congestion
▪ minor aches and pains
▪ sore throat
▪ temporarily reduces fever
▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
▪ skin reddening
▪ facial swelling
▪ asthma (wheezing)
Stomach bleeding warnings
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
▪ are age 60 or older
▪ have had stomach ulcers or bleeding problems
▪ take a blood thinning (anticoagulant) or steroid drug
▪ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
▪ have 3 or more alcoholic drinks every day while using this product
▪ take more or for a longer time than directed
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.
▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/fever reducer.
▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 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.
▪ in children under 12 years of age
▪ stomach bleeding warning applies to you
▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems
▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes or thyroid disease
▪ you have a cough with excessive phlegm (mucus)
▪ you have difficulty in urination due to enlargement of the prostate gland
▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- you have a chronic pulmonary disease or shortness of breath
▪ you have asthma
▪ you are taking a diuretic
▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.
▪ under a doctor’s care for any serious condition
do not use more than directed
▪ an allergic reaction occurs. Seek medical help right away.
▪ pain, cough, or nasal congestion 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
▪ ringing in the ears or a loss of hearing occurs
▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
▪ nervousness, dizziness, or sleeplessness occurs
▪ you experience any of the following signs of stomach bleeding:
▪ feel faint
▪ vomit blood
▪ have bloody or black stools
▪ have stomach pain that does not get better
ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away.
do not exceed recommended dosage.
- do not take more than 6 doses in any 24-hour period.
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliters
|adults and children 12 years of age and over||30 mL every 4 hours|
|children under 12 years of age||do not use|
▪ each 30mL contains: Sodium 16mg
▪ store at room temperature 68°- 86°F (20°- 30°C)
citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
|TOPCARE COUGH COLD AND FLU SIMPLE RELIEF
choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
|Labeler - TOPCO ASSOCIATES LLC (006935977)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.