alka-seltzer plus severe sinus cold and cough liquid gels

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name alka-seltzer plus severe sinus cold and cough liquid gels
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Labeler bayer healthcare llc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0507
Product ID 0280-0507_452662db-192f-a610-e063-6394a90a4a10
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2015-01-28

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02800507
Hyphenated Format 0280-0507

Supplemental Identifiers

RxCUI
1432488
UPC
0016500559504
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alka-seltzer plus severe sinus cold and cough liquid gels (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0280-0507-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

0280-0507-20 2 BLISTER PACK in 1 CARTON (0280-0507-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (250 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "452662db-192f-a610-e063-6394a90a4a10", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0016500559504"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1432488"], "spl_set_id": ["0dba1329-5b0d-5688-e054-00144ff8d46c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0280-0507-20)  / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0280-0507-20", "marketing_start_date": "20150128"}], "brand_name": "Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels", "product_id": "0280-0507_452662db-192f-a610-e063-6394a90a4a10", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0280-0507", "generic_name": "Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka-Seltzer Plus Severe Sinus Cold and Cough", "brand_name_suffix": "Liquid Gels", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150128", "listing_expiration_date": "20261231"}