topcare day time nite time cold and flu relief

Topco Associates LLC

Topco Associates LLC. Day Time Nite Time Cold & Flu Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients for Nighttime (in each 30 ml dose cup)
• Purpose Nighttime
• Active ingredients for Daytime (in each 15 ml tablespoon)
• Purpose Daytime
• topcare day time nite time cold and flu relief 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 these products
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• topcare day time nite time cold and flu relief Other information
• Inactive Ingredients
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients for Nighttime (in each 30 ml dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Active ingredients for Daytime (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

topcare day time nite time cold and flu relief Uses

temporarily relieves common cold/flu symptoms:

• •nasal congestion (Daytime only)
• •cough due to minor throat and bronchial irritation
• •sore throat
• •headache
• •minor aches and pains
• •fever
• •runny nose and sneezing (Nighttime only )

Warnings

Liver warning: These products contain acetaminophen. The maximum daily dose of these products is 4 doses (2,600 mg acetaminophen) in 24 hours (Nighttime) and 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours (Daytime). 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, which is the maximum daily amount (Daytime only)
• •taken with other drugs containing acetaminophen
• •adult has 3 or more alcoholic drinks every day while using these products

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 these products.
• •to make a child sleepy (Nighttime only)
• •if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• •taking sedatives or tranquilizers (Nighttime only)
• •taking the blood thinning drug warfarin

When using these products

• •do not use more than directed

In addition, when using Nighttime:

• •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 (Daytime only)
• •pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) (Daytime only)
• •pain or cough gets worse or lasts more than 7 days (Nighttime only)
• •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. (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 Liver warning
• •take Nighttime or Daytime
• •use dose cup
• •do not exceed 4 doses per 24 hrs

Nighttime

Daytime

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

topcare day time nite time cold and flu relief Other information

• •(Nighttime) each 30 mL dose cup contains: sodium 37 mg
• •(Daytime) each tablespoon contains: sodium 7 mg
• •store at 20°-25°C (68°-77°F)

Inactive Ingredients

Nighttime 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

Daytime butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Package/Label Principal Display Panel

MULTI-SYMPTOM RELIEF

Day Time Cold & Flu Relief

Pain Reliever – Fever Reducer

Acetaminophen

Cough Suppressant

Dextromethorphan HBr

Nasal Decongestant

Phenylephrine HCl

ORIGINAL FLAVOR

COMPARE TO VICKS® DAYQUIL® active ingredients

Alcohol Free

Antihistamine Free

Non-Drowsy

MULTI-SYMPTOM RELIEF

Nite Time Cold & Flu Relief

Pain Reliever – Fever Reducer

Acetaminophen

Cough Suppressant

Dextromethorphan HBr

Antihistamine

Doxylamine Succinate

ORIGINAL FLAVOR

COMPARE TO VICKS® NYQUIL® active ingredients

ALCOHOL 10%

SPECIAL VALUE!

COMBINATION PACK

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING