alka-seltzer plus day severe cold plus flu

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and 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 day severe cold plus flu
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler bayer healthcare llc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, dextromethorphan hydrobromide 20 mg/1, guaifenesin 400 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0921
Product ID 0280-0921_47e32f69-3232-a960-e063-6394a90a8590
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2014-04-17

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 02800921
Hyphenated Format 0280-0921

Supplemental Identifiers

RxCUI
1550968
UPC
0016500559429
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 day severe cold plus flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 20 mg/1
  • 400 mg/1
  • 10 mg/1
source: ndc
Packaging
  • PRINCIPAL DISPLAY PANEL - 6 Packet Carton Alka-Seltzer PLUS ® Severe Cold & Flu Honey Lemon Zest Fast Relief Mix-In Packets Day NON-DROWSY Acetaminophen / Pain reliever-fever reducer Phenylephrine HCl / Nasal decongestant Dextromethorphan HBr / Cough suppressant Guaifenesin / Expectorant • Nasal Congestion • Headache • Sore Throat • Body Ache • Cough • Mucus • Chest Congestion • Fever 6 PACKETS Carton 6
source: label

Packages (0)

No package records.

Ingredients (4)

acetaminophen (500 mg/1) dextromethorphan hydrobromide (20 mg/1) guaifenesin (400 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47e32f69-3232-a960-e063-6394a90a8590", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0016500559429"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1550968"], "spl_set_id": ["cec51eab-cce3-4965-a14e-a46d953050c4"], "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": [], "brand_name": "Alka-Seltzer Plus Day Severe Cold Plus Flu", "product_id": "0280-0921_47e32f69-3232-a960-e063-6394a90a8590", "dosage_form": "POWDER, FOR SOLUTION", "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": "0280-0921", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka-Seltzer Plus Day Severe Cold Plus Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140417", "listing_expiration_date": "20271231"}