FDA.reportPublic FDA data

COUGH BABY

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

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

Brand name
COUGH BABY
Generic name
IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT
Manufacturer
Hyland's Inc.
Product type
HUMAN OTC DRUG
SPL set ID
2daac16d-69d0-48bf-806f-f22c0a6973ad
SPL ID
4650bbda-1647-da3a-e063-6294a90a67fa
Version
11
Effective date
2025-12-19
Source export date
2026-08-01
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/a02fd54f2831abedf72de26b709069bc80ecbb9303a4823ffe5695ea1bb3d85a/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:40:10
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Ask a doctor before use if you have: ■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. Keep out of reach of children. Keep this and all medications out of the reach of children.