FDA Label for Topcare Nite Time Cold And Flu

Active Ingredients (In Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• •nasal congestion
• •sinus congestion and pressure
• •cough due to minor throat and bronchial irritation
• •cough to help you sleep
• •minor aches and pains
• •headache
• •fever
• •sore throat
• •runny nose and sneezing
• •reduces swelling of nasal passages
• •temporarily restores freer breathing through the nose
• •promotes nasal and/or sinus drainage

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.
• •to make a child sleepy
• •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
• •glaucoma
• •thyroid disease
• •diabetes
• •high blood pressure
• •trouble urinating due to an enlarged prostate gland
• •cough that occurs with too much phlegm (mucus)
• •a breathing problem such as emphysema or chronic bronchitis
• •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
• •taking sedatives or tranquilizers

When Using This Product

• •do not use more than directed
• •excitability may occur, especially in children
• •marked drowsiness may occur
• •avoid alcoholic drinks
• •be careful when driving a motor vehicle or operating machinery
• •alcohol, sedatives, and tranquilizers may increase drowsiness

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.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use

Other Information

• •each 15 mL contains: sodium 15 mg
• •store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

1-888-423-0139

Package/Label Principal Display Panel

TopCare_® health

COMPARE TO VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS

MAXIMUM STRENGTH RELIEF

Nite Time Cold & Flu

SEVERE

PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Nasal/Sinus Congestion & Sinus Pressure

• Sneezing, Runny Nose

• Cough

12 FL OZ (355 mL)

HONEY FLAVOR

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