Altituss

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: Altituss
Generic name: DEXTROMETHORPHAN HBR, GUAIFENESIN
Manufacturer: Alternative Pharmacal Corporation
Product type: HUMAN OTC DRUG
SPL set ID: e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44
SPL ID: 472ea5ae-3e91-42e3-e063-6294a90a4505
Version: 7
Effective date: 2025-12-30
Source export date: 2026-10-27
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/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:48:57

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		Altituss	openfda.brand_name
generic name		DEXTROMETHORPHAN HBR, GUAIFENESIN	openfda.generic_name
manufacturer name		Alternative Pharmacal Corporation	openfda.manufacturer_name
ndc	package	53163-113-16	openfda.package_ndc
ndc	product	53163-113	openfda.product_ndc
ndc11	package	53163011316	derived:openfda.package_ndc
rxcui		996520	openfda.rxcui
spl id		472ea5ae-3e91-42e3-e063-6294a90a4505	id
spl set id		e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	set_id
unii		9D2RTI9KYH	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 DO NOT USE If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product. Ask a doctor before use if you have: Cough that occurs with too much phlegm (mucus) Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema When using this product do not use more than directed. Stop use and ask a doctor before use if: cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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