FDA Label for Childrens Night Time Cough And Cold Relief
View Indications, Usage & Precautions
Childrens Night Time Cough And Cold Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, 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
Drug Facts
Active ingredients
(in each 5 mL tsp)
Diphenhydramine HCL,USP 6.25 mg
Phenylephrine HCL, USP 2.5 mg
Purpose
Antihistamine / Cough Suppressant
Nasal Decongestant
Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control center right away.
Uses
- temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold
- temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itchy nose or throat
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on the skin
- to make a child sleepy
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.
Ask A Doctor Before Use If The Child Has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If The Child Is
- taking sedatives or tranquilizers.
When Using This Product
- do not use more than directed
- 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 occus
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious condition.
Directions
- do not use more than directed
- do not take more than 6 doses in any 24-hour period
- use dosage cup or teaspoon
Other Information
- each teaspoonful contains: sodium 3 mg
- store between 20-25 ° C (68-77° F)
- do not refrigerate
- dosage cup provided
- Keep carton for full directions for use
Inactive Ingredients
acesulfame potassium, citric acid anhydrous, edeate disodium, FD and C blue #1, FD and C red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
Product Label
NDC 68016-143-00
*COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® CHILDREN'S NIGHT TIME COUGH and COLD
Premier Value®
Children's Night Time
COUGH and COLD RELIEF
Diphenhydramine HCL..........Antihistamine / Cough Suppressant
Phenylephrine HCL ............ Nasal Decongestant
Sneezing
Runny Nose
Cough
Stuffy Nose
Grape Flavored Liquid
4 FL OZ (118mL)
INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Delsym® Children's Night Time Cough and Cold
If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
BX-008
* Please review the disclaimer below.