Acetaminophen, Dextromethorphan HBr ,Guaifenesin

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 HBr ,Guaifenesin
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN
Manufacturer: Softgel Healthcare Pvt Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 353ef34f-760d-ae92-e063-6294a90a5b4a
SPL ID: 50039825-a8a4-cd65-e063-6294a90a5fd6
Version: 5
Effective date: 2026-04-27
Source export date: 2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:07:31

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Acetaminophen, Dextromethorphan HBr ,Guaifenesin	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN	openfda.generic_name
manufacturer name		Softgel Healthcare Pvt Ltd	openfda.manufacturer_name
ndc	package	35916-0184-3	openfda.package_ndc
ndc	package	35916-0184-2	openfda.package_ndc
ndc	package	35916-0184-4	openfda.package_ndc
ndc	product	35916-0184	openfda.product_ndc
ndc11	package	35916018403	derived:openfda.package_ndc
ndc11	package	35916018402	derived:openfda.package_ndc
ndc11	package	35916018404	derived:openfda.package_ndc
rxcui		2377385	openfda.rxcui
spl id		50039825-a8a4-cd65-e063-6294a90a5fd6	id
spl set id		353ef34f-760d-ae92-e063-6294a90a5b4a	set_id
unii		9D2RTI9KYH	openfda.unii
unii		362O9ITL9D	openfda.unii
unii		495W7451VQ	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 hrs, 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.