cold and cough daytime

Western Family Foods Inc

Western Family Cold and Cough Daytime Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each 15 mL = 1 tablespoon)
• Purpose
• cold and cough daytime Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• cold and cough daytime Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Purpose

Pain reliever

Cough suppressant

cold and cough daytime Uses

• •temporarily relieves:
• •headache
• •cough due to a cold
• •sore throat
• •minor aches and pains

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoons (3,000 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, 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.
• •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
• •cough that occurs with too much phlegm (mucus)
• •persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• •pain 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

• •do not take more than directed (see Liver warning)
• •use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

take 2 tablespoons (TBSP) in dose cup provided every 6 hours

do not take more than 6 tablespoons in 24 hoursdo not use this adult product in children under 12 years of age

•

•

•

adults & children 12 years & over
children under 12 years

Other information

• •each tablespoon contains: potassium 25 mg and sodium 8 mg
• •store between 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Principal Display Panel

See New Warnings and Directions

Non-Drowsy

COOL ICE®

Instant Cooling Sensation

Cold & Cough

ASPIRIN FREE

Pain Reliever, Cough Suppressant

DAYTIME

Sore Throat, Body Aches/Headache – Acetaminophen

Coughing – Dextromethorphan HBr

Gluten Free

COMPARE TO TYLENOL® COLD & COUGH active ingredients

cold and cough daytime Acetaminophen, Dextromethorphan HBr LIQUID Product Information Product Type Human otc drug label Item Code (Source) NDC:55312-700 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM FD&C BLUE NO. 1 POLYETHYLENE GLYCOLS propylene glycol water SODIUM BENZOATE sorbitol SUCROSE Product Characteristics Color BLUE (clear) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-700-34 237 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2006-03-21