alka-seltzer plus maximum strength sinus, congestion and pain power max gels

Generic: acetaminophen, dextromethorphan hydrobromide , 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, congestion and pain power max gels
Generic Name acetaminophen, dextromethorphan hydrobromide , phenylephrine hydrochloride
Labeler bayer healthcare llc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0095
Product ID 0280-0095_47e31806-7f5d-9a08-e063-6394a90ab71f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2021-08-01

Pharmacologic Class

Classes
adrenergic alpha1-agonists [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 02800095
Hyphenated Format 0280-0095

Supplemental Identifiers

RxCUI
1086997
UPC
0016500583493
UNII
362O9ITL9D 9D2RTI9KYH 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, congestion and pain power max gels (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide , phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0280-0095-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (0280-0095-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

0280-0095-01 2 BLISTER PACK in 1 CARTON (0280-0095-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 0280-0095-02 2 BLISTER PACK in 1 CARTON (0280-0095-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e31806-7f5d-9a08-e063-6394a90ab71f", "openfda": {"upc": ["0016500583493"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["e07931fc-f753-1aeb-e053-2a95a90ada3f"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0280-0095-01)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0280-0095-01", "marketing_start_date": "20210825"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0280-0095-02)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0280-0095-02", "marketing_start_date": "20210825"}], "brand_name": "Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels", "product_id": "0280-0095_47e31806-7f5d-9a08-e063-6394a90ab71f", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [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": "0280-0095", "generic_name": "Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210801", "listing_expiration_date": "20271231"}