FDA Label for Topcare Nite Time Cold And Flu

Active Ingredient (In Each 15 Ml Tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever
• runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than two 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

Ask A Doctor Before Use If You Have

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough as occurs with smoking, asthma or emphysema
• a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When Using This Product

• 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

• pain or cough 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
• 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.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 recommended – see Liver warning
• use dose cup
• do not exceed 4 doses per 24 hours

adults and children 12 years and over	30 mL (2 TBSP) every 6 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other Information

• each TBSP contains: sodium 18 mg
• store at 20°-25°C (68°-77°F)

Inactive Ingredients

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments?

1-888-423-0139

Principal Display Panel

See New Warnings Information

Cold & Flu

Multi-Symptom Relief

Nite Time

Pain Reliever, Fever Reducer - Acetaminophen

Cough Suppressant/Dextromethorphan HBr

Antihistamine/Doxylamine Succinate

Original Flavor

Compare to Vicks® NyQuil® active ingredients

10% Alcohol

Nite Time Cold and Flu Liquid Label - 7805c020 f15f 49d2 9c15 9f37a229e38e 01