Topcare Cold

Topco Associates LLC

Topco Associates LLC. Children’s Pain Relief Plus Multi-Symptom Cold Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL = 1 teaspoon)
• Purpose
• Topcare Cold Uses
• Warnings
  • Do not use
  • Ask a doctor before use if your child has
  • Ask a doctor or pharmacist before use if your child is
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• Topcare Cold Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Topcare Cold Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• •more than 5 doses in 24 hours, which is the maximum daily amount
• •with other drugs containing acetaminophen

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

• •in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
• •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• •to make a child sleepy
• •if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

• •liver disease
• •heart disease
• •high blood pressure
• •thyroid disease
• •diabetes
• •persistent or chronic cough such as occurs with asthma
• •cough that occurs with too much phlegm (mucus)
• •a breathing problem such as chronic bronchitis
• •glaucoma

Ask a doctor or pharmacist before use if your child is

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

When using this product

• •do not exceed recommended dosage
• •excitability may occur, especially in children
• •may cause marked drowsiness
• •sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• •nervousness, dizziness or sleeplessness occur
• •pain, nasal congestion or cough gets worse or lasts more than 5 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.

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 even if you do not notice any signs or symptoms.

Directions

• •this product does not contain directions or complete warnings for adult use
• •do not give more than directed (see Liver warning)
• •shake well before using
• •find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• •use only with enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• •if needed, repeat dose every 4-6 hours while symptoms last
• •do not give more than 5 times in 24 hours
• •do not give for more than 5 days unless directed by a doctor

Attention: Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Topcare Cold Other information

• •each teaspoon contains: sodium 3 mg
• •store between 20-25ºC (68-77ºF)
• •do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

ORAL SUSPENSION

Children’s Pain Relief Plus Multi-Symptom Cold

FEVER REDUCER

PAIN RELIEVER

ANTIHISTAMINE

COUGH SUPPRESSANT

NASAL DECONGESTANT

Contains 4 Ingredients:

Fever & Sore Throat

Acetaminophen

Sneezing & Runny Nose

Chlorpheniramine Maleate

Cough

Dextromethorphan HBr

Stuffy Nose

Phenylephrine HCl

GRAPE FLAVOR

COMPARE TO CHILDREN’S TYLENOL® PLUS MULTI-SYMPTOM COLD active ingredients