DRx Choice maximum strength Severe Cough plus sore throat

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: DRx Choice maximum strength Severe Cough plus sore throat
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR
Manufacturer: RARITAN PHARMACEUTICALS
Product type: HUMAN OTC DRUG
SPL set ID: a096cb76-0d1c-4ca8-854a-5199da0bc8f7
SPL ID: e236c8b2-9c58-4066-b509-001114e7000a
Version: 4
Effective date: 2026-09-09
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:56:45

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		DRx Choice maximum strength Severe Cough plus sore throat	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR	openfda.generic_name
manufacturer name		RARITAN PHARMACEUTICALS	openfda.manufacturer_name
ndc	package	68163-749-08	openfda.package_ndc
ndc	product	68163-749	openfda.product_ndc
ndc11	package	68163074908	derived:openfda.package_ndc
rxcui		1919076	openfda.rxcui
spl id		e236c8b2-9c58-4066-b509-001114e7000a	id
spl set id		a096cb76-0d1c-4ca8-854a-5199da0bc8f7	set_id
unii		9D2RTI9KYH	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 6 doses in any 24 hours period, which is the maximum daily amount ▪ 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.