FDA Label for Topcare Childrens Night Time Cold And Cough
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 5 ML)
- PURPOSES
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Topcare Childrens Night Time Cold And Cough 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)
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Purposes
Antihistamine/cough suppressant
Nasal decongestant
Uses
• temporarily relieves:• sneezing• itchy nose or throat• runny nose• 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
Do Not Use
• in a child under 4 years of age• 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 product containing diphenhydramine, even one used on skin• to make a child sleepy
Ask A Doctor Before Use If The Child Has
• heart disease• high blood pressure• thyroid disease• diabetes• glaucoma• cough that occurs with too much phlegm (mucus)• chronic cough that lasts or as occurs with asthma• a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers
When Using This Product
• do not exceed recommended dosage• may cause marked drowsiness• sedatives and tranquilizers may increase drowsiness• excitability may occur, especially in children
Stop Use And Ask A Doctor If
• nervousness, dizziness or sleeplessness occurs• symptoms do not get better within 7 days or occur with fever• cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign 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).
Directions
• may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.• use enclosed dosing cup only. Keep for use with this product only. 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• store at 20-25°C (68-77°F)
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions Or Comments?
1-888-423-0139
Package/Label Principal Display Panel
COMPARE TO CHILDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH ACTIVE INGREDIENTS
TRIACTING SYRUP
children’s Night Time Cold & Cough
ANTIHISTAMINE – COUGH SUPPRESSANT
DIPHENHYDRAMINE HCl
NASAL DECONGESTANT – PHENYLEPHRINE HCl
Cough Relief
Runny & Stuffy Nose
Itchy Throat
OUR PHARMACISTS RECOMMEND
Ages 6 to under 12 Years
GRAPE FLAVOR
4 FL OZ (118 mL)
* Please review the disclaimer below.