alka seltzer plus maximum strength sinus, allergy and cough power max gels

Generic: acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, 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 maximum strength sinus, allergy and cough power max gels
Generic Name acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride
Labeler bayer healthcare llc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0097
Product ID 0280-0097_47e323f5-7f72-a31e-e063-6394a90af3a9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2021-05-25

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] antihistamine [epc] histamine receptor antagonists [moa] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02800097
Hyphenated Format 0280-0097

Supplemental Identifiers

RxCUI
1297288
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 04JA59TNSJ

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 maximum strength sinus, allergy and cough power max gels (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0280-0097-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (0280-0097-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

0280-0097-01 2 BLISTER PACK in 1 CARTON (0280-0097-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 0280-0097-02 2 BLISTER PACK in 1 CARTON (0280-0097-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e323f5-7f72-a31e-e063-6394a90af3a9", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1297288"], "spl_set_id": ["e17eb929-209d-a2d1-e053-2a95a90a4cf3"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0280-0097-01)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0280-0097-01", "marketing_start_date": "20210825"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0280-0097-02)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0280-0097-02", "marketing_start_date": "20210825"}], "brand_name": "Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels", "product_id": "0280-0097_47e323f5-7f72-a31e-e063-6394a90af3a9", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "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": "0280-0097", "generic_name": "Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210525", "listing_expiration_date": "20271231"}