flo pms complete

Generic: acetaminophen, caffeine, pyrilamine maleate

Labeler: o positiv, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name flo pms complete
Generic Name acetaminophen, caffeine, pyrilamine maleate
Labeler o positiv, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, caffeine 60 mg/1, pyrilamine maleate 15 mg/1

Manufacturer
O Positiv, Inc.

Identifiers & Regulatory

Product NDC 83049-489
Product ID 83049-489_a0526808-00a6-42a5-aeb8-42db54626a28
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2022-12-05

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc] methylxanthine [epc]
Chemical Structure
xanthines [cs]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83049489
Hyphenated Format 83049-489

Supplemental Identifiers

RxCUI
1597298
UNII
362O9ITL9D 3G6A5W338E R35D29L3ZA
NUI
N0000175739 N0000175729 N0000175790 M0023046

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 flo pms complete (source: ndc)
Generic Name acetaminophen, caffeine, pyrilamine maleate (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 60 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (83049-489-08) / 8 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

83049-489-08 3 BLISTER PACK in 1 CARTON (83049-489-08) / 8 TABLET in 1 BLISTER PACK

Ingredients (3)

acetaminophen (500 mg/1) caffeine (60 mg/1) pyrilamine maleate (15 mg/1)

Linked Drug Pages (1)

FLO PMS Complete ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0526808-00a6-42a5-aeb8-42db54626a28", "openfda": {"nui": ["N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "3G6A5W338E", "R35D29L3ZA"], "rxcui": ["1597298"], "spl_set_id": ["cce62d9f-adb1-4473-8258-910dff6b1378"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "manufacturer_name": ["O Positiv, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (83049-489-08)  / 8 TABLET in 1 BLISTER PACK", "package_ndc": "83049-489-08", "marketing_start_date": "20221205"}], "brand_name": "FLO PMS Complete", "product_id": "83049-489_a0526808-00a6-42a5-aeb8-42db54626a28", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "83049-489", "generic_name": "Acetaminophen, Caffeine, Pyrilamine maleate", "labeler_name": "O Positiv, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FLO PMS Complete", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "CAFFEINE", "strength": "60 mg/1"}, {"name": "PYRILAMINE MALEATE", "strength": "15 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221205", "listing_expiration_date": "20261231"}