Topcare Nite Time Cold and Flu

Topco Associates LLC

Topco Associates LLC. Nite Time Cold & Flu Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each 30 mL dose cup)
• Purpose
• Topcare Nite Time Cold and Flu Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
• Keep out of reach of children.
• Directions
  • Topcare Nite Time Cold and Flu Other information
• Inactive ingredients
  • Questions or comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Topcare Nite Time Cold and Flu Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

• •more than 4,000 mg of acetaminophen in 24 hours
• •with other drugs containing acetaminophen
• •3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is 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
• •high blood pressure
• •thyroid disease
• •diabetes
• •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

Ask a doctor or pharmacist before use if you are

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

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 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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
• •use dose cup
• •do not exceed 4 doses per 24 hrs

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

Other information

• •each 30 mL dose cup contains: sodium 12 mg
• •store at 20°-25°C (68°-77°F)

Inactive ingredients

butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

MAXIMUM STRENGTH RELIEF

Nite Time Cold & Flu

Severe

Pain Reliever – Fever Reducer

Acetaminophen

Cough Suppressant

Dextromethorphan HBr

Antihistamine

Doxylamine Succinate

Nasal Decongestant

Phenylephrine HCl

MIXED BERRY FLAVOR

COMPARE TO VICKS® NYQUIL® SEVERE active ingredients

12 FL OZ (355 mL)