comfort-time

Generic: acetaminophen, caffeine, and pyrilamine maleate

Labeler: time cap labs, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH NOT FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name comfort-time
Generic Name acetaminophen, caffeine, and pyrilamine maleate
Labeler time cap labs, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Time Cap Labs, Inc

Identifiers & Regulatory

Product NDC 49483-347
Product ID 49483-347_7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH NOT FINAL
Application Number part343
Listing Expiration 2026-12-31
Marketing Start 2011-11-30

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 49483347
Hyphenated Format 49483-347

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 comfort-time (source: ndc)
Generic Name acetaminophen, caffeine, and pyrilamine maleate (source: ndc)
Application Number part343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 60 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 24 TABLET, FILM COATED in 1 BLISTER PACK (49483-347-24)
source: ndc

Packages (1)

49483-347-24 24 TABLET, FILM COATED in 1 BLISTER PACK (49483-347-24)

Ingredients (3)

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

Linked Drug Pages (1)

Comfort-Time ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5", "openfda": {"nui": ["N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "3G6A5W338E", "R35D29L3ZA"], "rxcui": ["1597298"], "spl_set_id": ["e94a26a2-36e5-4e1e-aea1-24e035c98043"], "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": ["Time Cap Labs, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 TABLET, FILM COATED in 1 BLISTER PACK (49483-347-24)", "package_ndc": "49483-347-24", "marketing_start_date": "20181214"}], "brand_name": "Comfort-Time", "product_id": "49483-347_7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "49483-347", "generic_name": "Acetaminophen, Caffeine, and Pyrilamine Maleate", "labeler_name": "Time Cap Labs, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Comfort-Time", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "CAFFEINE", "strength": "60 mg/1"}, {"name": "PYRILAMINE MALEATE", "strength": "15 mg/1"}], "application_number": "part343", "marketing_category": "OTC MONOGRAPH NOT FINAL", "marketing_start_date": "20111130", "listing_expiration_date": "20261231"}