TopCare Nighttime Cold & Flu Simple Relief
(choline salicylate, diphenhydramine hcI, phenylephrine hcl), solution
Topco Associates LLC
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Topco Associates LLC. Nighttime Cold & Flu Simple Relief
Drug Facts
Active ingredients (in each 30 mL)
Choline Salicylate (NSAID)* 870 mg
Diphenhydramine HCI 50mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
nonsteroidal anti-inflammatory drug*
Uses
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
Warnings
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.
Do not use
▪ 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
Ask a doctor before use if
▪ 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
Ask a doctor or pharmacist before use if you are
▪ 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
When using this product
▪ 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
Stop use and ask a doctor if
▪ 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
Directions
- do not exceed recommended dosage.
- do not take more than 6 doses in any 24-hour period.
- use enclosed dose cup
- keep dosage cup with product
- mL = milliliters
- adults and children 12 years of age and over: 30mL every 4 hours
- children under 12 years of age: do not use
Other information
- each 30mL contains: Sodium 16 mg
- tamper evident: Do not use if foil seal under cap is broken or missing.
- read all product information before using
- store at 68° to 86°F (20° to 30°C)
- avoid excessive heat and humidity
