Topcare Nite Time Day Time Cold and Flu Relief

Topco Associates LLC

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

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients for Nighttime (in each 15 ml tablespoon)
• Active ingredients for Daytime (in each 15 ml tablespoon)
• Purpose - Nighttime
  • Purpose - Daytime
• Topcare Nite Time Day 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 Nite Time Day Time Cold and Flu Relief Other information
• Inactive ingredients
• Questions or comments?
• Package/Label Principal Display Panel for Nighttime
• Package/Label Principal Display Panel for Daytime

FULL PRESCRIBING INFORMATION

Active ingredients for Nighttime (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for Daytime (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose - Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Topcare Nite Time Day 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: This product contains acetaminophen. Severe liver damage may occur if

• •adult takes more than 4 doses in 24 hours, which is the maximum daily amount for this product
• •child takes more than 4 doses in 24 hours (Daytime only)
• •taken with other drugs containing acetaminophen
• •adult has 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 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 Nite Time Day Time Cold and Flu Relief Other information

(Nighttime) each tablespoon contains: sodium 19 mg

(Daytime) each tablespoon contains: sodium 7 mg

store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, 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

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel for Nighttime

See New Warnings and Dosing Information

MULTI-SYMPTOM RELIEF

Nite Time Cold & Flu Relief

Pain Reliever / Fever Reducer / Acetaminophen

Cough Suppressant / Dextromethorphan HBr

Antihistamine / Doxylamine Succinate

CHERRY FLAVOR

COMPARE TO VICKS® NYQUIL® active ingredients

10 FL OZ (296 ml)

NIGHTTIME

ALCOHOL 10%

SPECIAL VALUE!

COMBINATION PACK

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Package/Label Principal Display Panel for Daytime

See New Warnings and Dosing Information

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

10 FL OZ (296 ml)

DAYTIME

Non-Drowsy

SPECIAL VALUE!

COMBINATION PACK

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING