1. Home
  2. Labeler Index
  3. L. Perrigo Company
  4. 0113-0903
  5. Label Information: Good Sense Cold

FDA Label for Good Sense Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML, 1 TEASPOONFUL)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE 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

Good Sense Cold Product Label

The following document was submitted to the FDA by the labeler of this product L. Perrigo Company. 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, 1 Teaspoonful)



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
  • •cough due to minor throat and bronchial irritation as may occur with a cold
  • •runny nose
  • •itchy nose or throat
  • •itchy, watery eyes due to hay fever
  • •nasal and sinus congestion
  • •sneezing
  • •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
  • •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
  • •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.
  • •if your child has ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If The 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 The Child Is Taking



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

When Using This Product



  • •do not exceed recommended dosage
  • •excitability may occur, especially in children
  • •marked drowsiness may occur
  • •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.



Overdose warning: 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 Overdose warning)
  • •shake well before using
  • •may be given every 4-6 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

    2 teaspoonfuls (10 mL)

    •  teaspoonful = tsp

Other Information



  • •each teaspoonful contains: sodium 3 mg
  • •store between 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?



1-800-719-9260


Principal Display Panel



Ages 6 – 11 Years

See New Warnings

Children’s

Triacting Suspension

Multi-Symptom

Cold Plus

Fever Reducer/Pain Reliever, Cough Suppressant, Nasal Decongestant, Antihistamine

Fever & Sore Throat – Acetaminophen

Cough – Dextromethorphan HBr

Stuffy Nose – Phenylephrine HCl

Sneezing & Runny Nose – Chlorpheniramine Maleate

Grape Flavor

Compare to active ingredients of Children’s Triaminic® Multi-Symptom Fever & Cold

4 FL OZ (118 mL)

GoodSense Multi-Symptom Cold Plus Image 1 - image 01

GoodSense Multi-Symptom Cold Plus Image 1 - image 01


* Please review the disclaimer below.