Active Ingredients (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Nighttime Cold And Cough Liquid
FDA Label NDC 82673-191
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 Nighttime Cold And Cough (NDC 82673-191). 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
Uses
temporarily relieves:
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies
- the impulse to cough
- cough to help you get to sleep
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritant
- the intensity of coughing
Do Not Use
- in a child under 4 years of age
- 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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- diabetes
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
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
- alcohol, sedatives and tranquilizers may increase drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If Pregnant Or Breat-Feeding,
ask a health professional before use.
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
- adults and children 6 years and over: do not exceed 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
- shake well before using
- mL= milliliter
| Age | Dose |
| adults and children 12 years of age and over | 10 mL every 4 hours |
| children 6 to under 12 years of age | 5 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 |
Inactive Ingredients
Organic agave syrup, non-GMO citric acid, organic natural flavor, purified water
Other Information
- store between 20-25° (68-77°F).
- Do not refrigerate
- protect from light
Questions?
Call 424-235-0355
Principal Display Panel
KIDS' Ages 6+
NIGHTTIME
COLD & COUGH
Diphenhydramine HCl 12.5 mg per 5 mL
Antihistamine/Cough Suppressant
Organic Cherry Flavor
DOSING CUP INCLUDED
FL OZ (mL)
TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING
DISTRIBUTED BY: KinderFarms®
Redondo Beach, CA 90277 USA
Package Label
KINDERMED Kids Nighttime Cold & Cough Cherry Flavor
* Please review the disclaimer below.
