Cold Plus Head Congestion Day And Night Kit
FDA Label NDC 36800-927

COLD + HEAD CONGESTION DAY

Drug Facts

COLD + HEAD CONGESTION NIGHT

Drug Facts

• for the temporary relief of the following cold symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sinus congestion and pressure
  • helps clear nasal passages
  • temporarily reduces fever
  • for the temporary relief of the following cold symptoms:
    
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose and sneezing
    • cough
    • sinus congestion and pressure
    • helps clear nasal passages
    • relieves cough to help you sleep
    • temporarily reduces fever

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 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

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.

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.

• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

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

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

• do not exceed recommended dosage

In addition, when using Cold + Head Congestion Night:

• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

• nervousness, dizziness, or sleeplessness occur
• 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.

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.

• do not take more than directed (see overdose warning)
• do not take Day and Night caplets at the same time
• do not take more than a total of 10 caplets in 24 hours

adults and children 12 years and over	take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve
children under 12 years	ask a doctor

• store between 20-25°C (68-77°F) in a dry place
• retain carton for complete product information and warnings

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

NDC 36800-927-02

For Adults

TopCare® Health™

Cold + Head Congestion Day +Night

Pharmacists Recommend

Daytime Non-Drowsy

Pain Reliever/Fever Reducer - Acetaminophen

Cough Suppressant – Dextromethorphan HBr

Nasal Decongestant - Phenylephrine HCl

Day Caplet Relieves:

Headache + Body Aches

Fever + Sore Throat

Cough

Nasal Congestion

12 Cool Taste Caplets

Nighttime

Pain Reliever/Fever Reducer - Acetaminophen

Cough Suppressant – Dextromethorphan HBr

Nasal Decongestant - Phenylephrine HCl

Antihistamine* – Chlorpheniramine Maleate*

Night Caplet Relieves:

Headache + Body Aches

Fever + Sore Throat

Cough

Nasal Congestion

Runny Nose*

*Antihistamine in Nighttime Only

8 Cool Taste Caplets