Childrens Nighttime Cold and Cough

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Childrens Nighttime Cold and Cough
Generic name
DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
Manufacturer
KinderFarms, LLC
Product type
HUMAN OTC DRUG
SPL set ID
40904eb3-723c-4ddc-8a0e-5ae5ef74c259
SPL ID
0e313a2c-47dd-4188-8e2d-ed0faabe28e1
Version
3
Effective date
2024-04-10
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:14:50
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.