Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate

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: Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE
Manufacturer: Softgel Healthcare Private Limited
Product type: HUMAN OTC DRUG
SPL set ID: 229d1939-84a9-f18e-e063-6394a90aba30
SPL ID: 47c7c8ae-62c2-383d-e063-6294a90a15fe
Version: 2
Effective date: 2026-01-28
Source export date: 2026-10-27
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/a758d73d4d838a965005e6adf01b928e2da86f99be0f8bbaeeb95f3b7acbe418/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:58:53

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	openfda.generic_name
manufacturer name		Softgel Healthcare Private Limited	openfda.manufacturer_name
ndc	package	35916-0154-1	openfda.package_ndc
ndc	product	35916-0154	openfda.product_ndc
ndc11	package	35916015401	derived:openfda.package_ndc
rxcui		1094549	openfda.rxcui
spl id		47c7c8ae-62c2-383d-e063-6294a90a15fe	id
spl set id		229d1939-84a9-f18e-e063-6394a90aba30	set_id
unii		9D2RTI9KYH	openfda.unii
unii		V9BI9B5YI2	openfda.unii
unii		362O9ITL9D	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

Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days,is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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