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  5. Label Information: Topcare Cold

FDA Label for Topcare Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS TAKING
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Topcare Cold Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 5 Ml)



Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg


Purposes



Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant


Uses



  • •temporarily relieves
  • •minor aches and pains
  • •headache
  • •minor sore throat pain
  • •runny nose
  • •itchy nose or throat
  • •sneezing
  • •itchy, watery eyes due to hay fever
  • •nasal and sinus congestion
  • •cough due to minor throat and bronchial irritation as may occur with a cold
  • •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

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • •skin reddening
    • •blisters
    • •rash

      • If a skin reaction occurs, stop use and seek medical help right away.

      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 under 4 years of age
  • •if your child has ever had an allergic reaction to this product or any of its ingredients
  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • •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.
  • •to make a child sleepy

Ask A Doctor Before Use If Your Child Has



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

Ask A Doctor Or Pharmacist Before Use If Your Child Is Taking



  • •sedatives or tranquilizers
  • •blood thinning drug warfarin

When Using This Product



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

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.



Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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 Overdose warning)
  • •shake well before using
  • •remove the child protective cap and squeeze your child’s dose into the dosing cup
  • •may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
  • •use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.

    • Age

    Dose

    children under 4

    years of age

    do not use

    children 4 to under 6

    years of age

    do not use unless directed by a doctor

    children 6 to under 12 years of age

    10 mL


Other Information



  • •each 5 mL contains: sodium 3 mg
  • •contains no aspirin
  • •store at 20-25°C (68-77°F). Protect from light.
  • •close cap tightly

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



COMPARE TO CHILDREN’S TRIAMINIC® MULTI-SYMPTOM FEVER & COLD

ACTIVE INGREDIENTS

TRIACTING SUSPENSION

children’s Pain Relief Plus Multi-Symptom Cold

OUR PHARMACISTS RECOMMEND

FEVER REDUCER - PAIN RELIEVER - ACETAMINOPHEN

COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

NASAL DECONGESTANT - PHENYLEPHRINE HCl

ANTIHISTAMINE - CHLORPHENIRAMINE MALEATE

Cold & Flu Symptom Relief

Runny & Stuffy Nose

Aches & Pains

Fever

Sore Throat

Cough

Ages 6 to under 12 Years

GRAPE FLAVOR

4 FL OZ (118 mL)


* Please review the disclaimer below.