TopCare Nighttime Cold and Flu Simple Relief

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

 

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.

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

If pregnant or breast-feeding,

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.

Keep out of reach of children.

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.
  
• 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

• 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

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)

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]