Active Ingredients (In Each 5 Ml)
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Childrens Nighttime Cold And Cough Liquid
FDA Label NDC 82673-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kinderfarms, Llc for the product Childrens Nighttime Cold And Cough (NDC 82673-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purposes, uses, do not use, ask a doctor before use if the chld has, ask a doctor or pharmacist before use if the child is, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antihistamine/
Cough suppressant
Nasal decongestant
Uses
temporarily relieves:
- sneezing
- runny nose
- itchy nose or throat
- 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 contains an MAOI, ask a doctor or pharmacist before giving this product.
- with any other product containing diphenhydramine, even one used on skin
- for the purpose of making your child sleepy
Ask A Doctor Before Use If The Chld 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
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.
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 (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24-hours unless directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL= milliliter
- shake well before using
| age | dose |
| children 6 to under12 years of age | 10 mL every 4 hours |
| children 4 to under 6 years of age | do not use unless directed by a doctor |
| children under 4 years of age | do not use |
Other Information
- store between 20-25° (68-77°F)
- do not refrigerate
- protect from light
Inactive Ingredients
Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water
Questions?
Call 424-235-0355
Principal Display Panel
KIDS NIGHTTIME COLD & COUGH Age 6-11 yrs
Diphenhydramine HCl 6.25 mg per 5 mL
Antihistamine/ Cough Suppressant
Phenylephrine HCl 2.5 mg per 5 mL
Nasal Decongestant
Organic Cherry Flavor
NO COMMON ALLERGENS.
NO DYES OR PARABENS.
DOSING CUP INCLUDED
FL OZ (mL)
TAMPER EVIDENT: BOTTLE IS SAFETY SEALED. DO NOT USE IF BOTTLE SEAL IS BROKEN OR MISSING.
Keep outer carton for complete warnings and product information.
DISTRIBUTED BY: KinderFarms®
Redondo Beach, CA 90277 USA
kinderfarms.com
Package Label
KINDERMED Kids Nighttime Cold & Cough Organic Cherry Flavor
* Please review the disclaimer below.
