FDA label 0cfebacc-e6d5-fab0-e063-6294a90a41ba

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
781e94d5-1d5c-7202-e053-2991aa0ae768
SPL ID
0cfebacc-e6d5-fab0-e063-6294a90a41ba
Version
2
Effective date
2023-12-20
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:38:51

Warnings cross-check#

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

Warnings sections page 1 of 2 · 8 matching rows.

warnings

Fortify For external use only . Do not take by mouth or place in nostrils. Flammable : Keep away from fire or flame. Do not use • if epileptic • with high blood pressure. Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus). When using this product , do not • heat • microwave • use near an open flame • add to hot water or any container where heating water. May cause splattering and result in burns. 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 breast-feeding, do not use this product. Fortify Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.

warnings

Pain Release For external use only. Flammable . Keep away from fire or flame. Do not use • on wounds or damaged skin • if epileptic • with high blood pressure. When using this product • avoid contact with the eyes • do not bandage tightly. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding , do not use this product. Pain Release Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

warnings

Peppermint Halo Warnings: - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - if skin sensitization occurs, rinse with vegetable oil. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding, with high/low blood pressure, or if epileptic. - if allergic reaction occurs, stop use & consult a doctor.

warnings

Gutzy - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding or if epileptic. - if allergic reaction occurs, stop use & consult a doctor.

Reported adverse events (FAERS/openFDA)#

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