Topcare Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Topcare Cold

Topco Associates LLC

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


FULL PRESCRIBING INFORMATION: CONTENTS*




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

Weight (lb)

Age (yr)

Dose (tsp or mL)

under 36 lbs

under 4 years

do not use

36-47 lbs

4-5 years

do not use unless directed by a doctor

48-95 lbs

6-11 years

2 tsp or 10 mL

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

Topcare Cold

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-903
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
CALCIUM SULFATE
CARRAGEENAN
D&C RED NO. 33
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
polysorbate 80
water
SODIUM BENZOATE
sorbitol
SUCROSE
SODIUM PHOSPHATE, TRIBASIC
XANTHAN GUM

Product Characteristics

Color
PURPLE (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:36800-903-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-07-24


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Be sure to consult your doctor before taking any medication!
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