FDA label ac836f01-c9bf-45e3-8568-dbcce74dcf5a

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)

SPL set ID
35e3d154-f914-426d-a702-328cbc27ceba
SPL ID
ac836f01-c9bf-45e3-8568-dbcce74dcf5a
Version
6
Effective date
2022-07-20
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:51:14

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use • to make a child sleepy • in a child under 6 years of age • with any other drug containing diphenhydramine, even one used on the skin • in a child now 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 using this product. Ask a doctor before use if your child has • heart disease • diabetes • high blood pressure • thyroid disease • glaucoma • trouble urinating due to an enlarged prostate gland • breathing problems such 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 your child is taking sedatives or tranquilizers When using this product • do not use more than directed • excitability in your child may occur • marked drowsiness in your child may occur • 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 lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. Keep out of reach of children.Dr. Cocoa TM is a medicine. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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