FDA label a485bd93-ce06-59cc-e053-2995a90ab0f0

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
7abace52-4d9c-429b-b9a9-96d06261ef50
SPL ID
a485bd93-ce06-59cc-e053-2995a90ab0f0
Version
2
Effective date
2020-04-30
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:57

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: Warnings: Do not use - Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. 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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. With any other product containing diphenhydramine,even one used on skin. Ask a doctor before use If you have: heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due an enlarged prostate gland cough that occurs that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product: do not exceed recommended dosage may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if: you get nervous, dizzy, or sleeplessness occurs symptoms do not improve within 7 days, tend 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 breast-feeding, ask a health professional before use.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: To report serious side effects associated with the use of this product call the Poison Control Center.

Reported adverse events (FAERS/openFDA)#

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