Nighttime Severe Cold and Cough

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: Nighttime Severe Cold and Cough
Generic name: ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
Manufacturer: RARITAN PHARMACEUTICALS INC
Product type: HUMAN OTC DRUG
SPL set ID: 9819155b-2713-42be-867e-16605e7643d0
SPL ID: 7fd2aabb-24db-49c6-a943-74dc35da3877
Version: 8
Effective date: 2026-09-08
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:18:34

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		Nighttime Severe Cold and Cough	openfda.brand_name
generic name		ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	openfda.generic_name
manufacturer name		RARITAN PHARMACEUTICALS INC	openfda.manufacturer_name
ndc	package	68163-541-06	openfda.package_ndc
ndc	product	68163-541	openfda.product_ndc
ndc11	package	68163054106	derived:openfda.package_ndc
rxcui		1659960	openfda.rxcui
spl id		7fd2aabb-24db-49c6-a943-74dc35da3877	id
spl set id		9819155b-2713-42be-867e-16605e7643d0	set_id
unii		04JA59TNSJ	openfda.unii
unii		TC2D6JAD40	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 4,000 mg of acetaminophen in 24 hours ▪ 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.