Formula 3 Cough Syrup

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: Formula 3 Cough Syrup
Generic name: COUGH SYRUP
Manufacturer: Vitality Works, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 199bbe91-ebfe-45fa-acba-62b35c7e6fba
SPL ID: 462f5bc0-eea2-2be8-e063-6294a90a958d
Version: 9
Effective date: 2025-12-17
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:46:29

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Formula 3 Cough Syrup	openfda.brand_name
generic name		COUGH SYRUP	openfda.generic_name
manufacturer name		Vitality Works, Inc.	openfda.manufacturer_name
ndc	package	64616-072-01	openfda.package_ndc
ndc	product	64616-072	openfda.product_ndc
ndc11	package	64616007201	derived:openfda.package_ndc
spl id		462f5bc0-eea2-2be8-e063-6294a90a958d	id
spl set id		199bbe91-ebfe-45fa-acba-62b35c7e6fba	set_id
unii		5D48E975HA	openfda.unii
unii		07V4DX094T	openfda.unii
unii		H6J53HEX8E	openfda.unii

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

Formula 3 Cough Syrup Do not give product for persistent or chronic cough such as occurs with asthma or if cough is accompanied excessive phlegm (mucus) unless directed by doctor. 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, as a persistent cough may be a sign of a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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