cold relief

Western Family Foods Inc

Western Family Cold Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet) (NIGHT)
• Active ingredient (in each caplet) (DAY)
• Purpose (NIGHT)
• Purpose (DAY)
• cold relief Uses (NIGHT)
• cold relief Uses (DAY)
• Warnings (NIGHT)
  • 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,
• Warnings (DAY)
  • 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 (NIGHT)
• Directions (DAY)
• Inactive ingredients (NIGHT)
• Inactive ingredients (DAY)
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet) (NIGHT)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredient (in each caplet) (DAY)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (NIGHT)

Pain reliever

Antihistamine

Cough suppressant

Nasal decongestant

Purpose (DAY)

Pain reliever

Cough suppressant

Nasal decongestant

Uses (NIGHT)

• temporarily relieves these common cold symptoms:
• headache
• nasal congestion
• minor aches and pains
• cough
• sore throat
• sinus congestion and pressure
• sneezing and runny nose
• helps clear nasal passages
• relieves cough to help you sleep

Uses (DAY)

• temporarily relieves these common cold symptoms:
• headache
• nasal congestion
• minor aches and pains
• cough
• sore throat
• sinus congestion and pressure
• helps clear nasal passages

Warnings (NIGHT)

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

• more than 12 caplets 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 2 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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that lasts or is chronic 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

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
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

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.

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.

Warnings (DAY)

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

• more than 12 caplets 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 2 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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

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.

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 (NIGHT)

• do not take more than directed (see Liver warning)
• do not take the Day and Night caplets at the same time
• do not take more than a total of 12 caplets in 24 hours

Directions (DAY)

• do not take more than directed (see Liver warning)
• do not take the Day and Night caplets at the same time
• do not take more than a total of 12 caplets in 24 hours

Inactive ingredients (NIGHT)

acesulfame potassium, blue no. 1 lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (DAY)

acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

Principal Display Panel

See New Warnings Information

COOL ICE® CAPLETS

Instant Cooling Sensation

Cold Relief

ASPIRIN FREE

Pain Reliever, Nasal Decongestant, Cough Suppressant, †Antihistamine

DAYTIME

Headache/Sore Throat – Acetaminophen

Nasal Congestion – Phenylephrine HCl

Coughing – Dextromethorphan HBr

Non-Drowsy

NIGHTTIME

Headache/Sore Throat – Acetaminophen

Nasal Congestion – Phenylephrine HCl

Coughing – Dextromethorphan HBr

Runny Nose – Chlorpheniramine Maleate

†Antihistamine in Nighttime Only

COMPARE TO TYLENOL® COLD HEAD CONGESTION DAY AND NIGHT active ingredients