Active Ingredients (In Each 30 Ml)
Choline Salicylate (NSAID)* 870 mg
Diphenhydramine HCI 50mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Nighttime Cold And Flu Simple Relief (NDC 36800-888). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 30 ml), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Choline Salicylate (NSAID)* 870 mg
Diphenhydramine HCI 50mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
nonsteroidal anti-inflammatory drug*
temporarily relieves these common cold and flu symptoms:
▪ nasal congestion
▪ minor aches and pains
▪ runny nose
▪ sneezing
▪ watery eyes
▪ sore throat
▪ headache
▪ temporarily reduces fever
Reye's syndrome
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.
Allergy alert
Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
▪ hives
▪ rash
▪ shock
▪ 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.
▪ with any other drug containing diphenhydramine, even one used on the skin
▪ 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, thyroid disease, or glaucoma
▪ you have a cough with excessive phlegm (mucus)
▪ you have difficulty in urination due to enlargement of the prostate gland
▪ you have breathing problems such as emphysema or chronic bronchitis
▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.
▪ taking a diuretic
▪ under a doctor’s care for any serious condition
▪ taking sedatives or tranquilizers
▪ do not use more than directed
▪ excitability may occur, especially in children
▪ marked drowsiness may occur
▪ alcohol, sedatives, and tranquilizers may increase drowsiness
▪ avoid alcoholic drinks
▪ be careful when driving a motor vehicle or operating machinery
▪ 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.
citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
Call 1-888-423-0139
NDC 36800-888-08
Nighttime
Cold & Flu
Simple Relief
8 FL OZ (237mL)
* Please review the disclaimer below.