Green Guard PMS Relief

Product NDC
47682-016
11-digit product format
476820016
Labeler code
47682
Product ID
47682-016_da5a0612-7917-368c-e053-2a95a90a6381
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, PAMABROM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-12-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; PAMABROM
Active strength
325 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct47682-016DDiscontinued by firm2026-07-31
excluded packagepackage47682-01647682-016-33DDiscontinued by firm2026-07-31
excluded packagepackage47682-01647682-016-48DDiscontinued by firm2026-07-31
excluded packagepackage47682-01647682-016-99DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.7dbd0a2d-8597-4010-bfe2-94a8d145ca572026-03-27WarningsExact identifier
AcetaminophenACETAMINOPHENAphena Pharma Solutions - Tennessee, LLC89134c3e-ec5b-4a57-952a-98d6c6cff7c22019-02-26WarningsExact identifier
CounterAct PMACETAMINOPHEN AND DIPHENHYDRAMINEMelaleuca, Inc.7f9a0062-0e86-1deb-e053-2a91aa0a91882019-01-18WarningsExact identifier
Low Dose Miniprin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc5a38a643-55b0-4a6c-84e1-ee23744351142018-12-19WarningsExact identifier
Low Dose Aspirin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc55d645bb-8645-4984-a7b9-3e6eed8c64122018-12-17WarningsExact identifier
ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC2569383a-4a05-4ddb-852e-b37e487ffcde2018-12-17WarningsExact identifier
Low Dose Aspirin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc9cb0c2df-5e72-42c5-ae93-144201fd263c2018-12-17WarningsExact identifier
ASPIRIN EXTRA STRENGTHASPIRINTime-Cap Labs, Incefc7d42a-241a-422d-bc08-be2f5f774b622018-12-17WarningsExact identifier
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc5aaf8b66-b00e-4bc8-972c-bbe6825284fb2018-12-17WarningsExact identifier
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc7146c505-2469-4bc2-9e1e-ceb60951c8ae2018-12-17WarningsExact identifier
Comfort-TimeACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATETime Cap Labs, Ince94a26a2-36e5-4e1e-aea1-24e035c980432018-12-14WarningsExact identifier
Aspirin Delayed ReleaseASPIRINTime-Cap Labs, Inc70d8ba6c-8dfe-402a-817d-22544141d1602018-12-14WarningsExact identifier
Geritrex AspirinASPIRINGeritrex LLC93fb4359-c93d-46c4-b36e-611b829f514c2018-10-10WarningsExact identifier
Pain Relief PMACETAMINOPHEN PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
AcetaminophenACETAMINOPHENVelocity Pharma LLCbba2ddc5-19e0-4f11-8ff7-7dd7c2d53b502018-05-14WarningsExact identifier
AspirinASPIRINAphena Pharma Solutions - Tennessee, LLC49f46b08-b2fe-4e4d-b235-983dab9740cc2018-02-18WarningsExact identifier
AcetaminophenACETAMINOPHENAdvance Pharmaceutical Inc.3793a17e-13bf-4d27-b8fa-6753b760f8202017-12-22WarningsExact identifier
APAPACETAMINOPHENAdvance Pharmaceutical Inc.aba26f0a-94e4-4919-a3b0-033e3a9598ef2017-12-22WarningsExact identifier
APAPACETAMINOPHENAdvance Pharmaceutical Inc.5c75dc7f-06ae-440e-90ed-d7753eaa786e2017-12-22WarningsExact identifier
Extra Strength AcetaminophenACETAMINOPHENPuraCap Pharmaceutical LLCf3c57374-1408-4459-a4de-ad12c2fc6b612017-11-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if • pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
PAMABROMACTIVE INGREDIENTUA8U0KJM72GREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
BROMOTHEOPHYLLINEACTIVE MOIETYFZG87K1MQ6GREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
SUCROSEINACTIVE INGREDIENTC151H8M554GREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-016-334768200163350 PACKET in 1 BOX (47682-016-33) > 2 TABLET, FILM COATED in 1 PACKET50 packet2008-12-300000-00-00NoNoCurrent
47682-016-4847682001648125 PACKET in 1 BOX (47682-016-48) > 2 TABLET, FILM COATED in 1 PACKET (47682-016-99) 125 packet2008-12-300000-00-00NoNoCurrent
47682-016-99476820016992 TABLET, FILM COATED in 1 PACKET (47682-016-99) 2008-12-300000-00-00NoNoCurrent