Topcare Cold and Cough

Topco Associates LLC

Topco Associates LLC. Cold & Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each 15 mL = 1 tablespoon)
• Purpose
• Topcare 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
• Topcare 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

Topcare 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.

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

Topcare Cold and Cough Other information

• •each tablespoon contains: potassium 25 mg and sodium 8 mg
• •store between 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?

1-888-423-0139

Principal Display Panel

NIGHTTIME

Pain Relief

See New Warnings and Directions

Cold & Cough

PAIN RELIEVER/COUGH SUPPRESSANT

ANTIHISTAMINE

Sore Throat / Body Aches / Headache – Acetaminophen

Coughing / Dextromethorphan HBr

Runny Nose / Doxylamine Succinate

COOL ICE® Instant Cooling Sensation

COMPARE TO TYLENOL® COLD & COUGH NIGHTTIME active ingredients

8 FL OZ (237 ml)

Topcare Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID Product Information Product Type Human otc drug label Item Code (Source) NDC:36800-703 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 DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 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:36800-703-34 237 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2006-03-09