CareOne Cold and Cough

American Sales Company

American Sales Company Cold & Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each 15 mL = 1 tablespoon)
• Purpose
• CareOne Cold and Cough 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 this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• CareOne Cold and Cough Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever

Cough suppressant

Antihistamine

CareOne Cold and Cough Uses

• •temporarily relieves the following cold/flu symptoms:
• •minor aches and pains
• •headache
• •sore throat
• •runny nose and sneezing
• •cough

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
• •to make a child sleepy

Ask a doctor before use if you have

• •liver disease
• •glaucoma
• •trouble urinating due to an enlarged prostate gland
• •a breathing problem such as emphysema or chronic bronchitis
• •persistent or chronic cough 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
• •taking sedatives or tranquilizers

When using this product

• •excitability may occur, especially in children
• •may cause marked drowsiness
• •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

• •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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 overdose warning)
• •use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

CareOne Cold and Cough Other information

• •each tablespoon contains: potassium 25 mg and sodium 8 mg
• •store at 20-25°C (68-77°F). Do not refrigerate.

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredients in Tylenol® Cold & Cough Nighttime

PAIN RELIEF

COLD & COUGH

PAIN RELIEVER – COUGH SUPPRESSANT – ANTIHISTAMINE

Sore Throat/Body Aches/Headache – Acetaminophen

Coughing – Dextromethorphan HBr

Runny Nose – Doxylamine Succinate

NIGHTTIME

Instant Cooling Sensation

8 FL OZ (237 mL)