Ultra Seal Corporation

FDA Drug Class II Terminated

Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040

January 24, 2022 Ultra Seal Corporation 1,351,660 packets units

FDA Drug Class II Terminated

PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00

January 24, 2022 Ultra Seal Corporation 111,300 packets units

FDA Drug Class II Terminated

CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895

January 24, 2022 Ultra Seal Corporation 241,560 bottles units

FDA Drug Class II Terminated

Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124

January 24, 2022 Ultra Seal Corporation 1,1401,641 packets units

FDA Drug Class II Terminated

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00

January 24, 2022 Ultra Seal Corporation 122,400 packets units

FDA Drug Class II Terminated

Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

January 24, 2022 Ultra Seal Corporation 227,010 packets units

FDA Drug Class II Terminated

AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

January 24, 2022 Ultra Seal Corporation 216,000 packets units

FDA Drug Class II Terminated

Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00

January 24, 2022 Ultra Seal Corporation 1,180,000 packets units

FDA Drug Class II Terminated

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American

January 24, 2022 Ultra Seal Corporation 313,000 packets units

FDA Drug Class II Terminated

SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

January 24, 2022 Ultra Seal Corporation 448,300 packets units

FDA Drug Class II Terminated

REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487

January 24, 2022 Ultra Seal Corporation 40,344 blisters units

FDA Drug Class II Terminated

CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seatt

January 24, 2022 Ultra Seal Corporation 225,000 packets units

FDA Drug Class II Terminated

ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

January 24, 2022 Ultra Seal Corporation 1,474,050 packets units

FDA Drug Class II Terminated

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68

January 24, 2022 Ultra Seal Corporation 887,000 packets units

FDA Drug Class II Terminated

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832

January 24, 2022 Ultra Seal Corporation 5,107,565 packets units

FDA Drug Class II Terminated

MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6

January 24, 2022 Ultra Seal Corporation 90,072 bottles units

FDA Drug Class II Terminated

COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-255

January 24, 2022 Ultra Seal Corporation 226,400 packets units

FDA Drug Class II Terminated

PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060

January 24, 2022 Ultra Seal Corporation a)131,112 packets, b) 8,064 bottles units

FDA Drug Class II Terminated

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

January 24, 2022 Ultra Seal Corporation 226,390 packets units

FDA Drug Class II Terminated

REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487

January 24, 2022 Ultra Seal Corporation a) 308,928 blisters b) 29,808 blisters units

FDA Drug Class II Terminated

Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC

January 24, 2022 Ultra Seal Corporation 1,236,000 packets units

FDA Drug Class II Terminated

Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24

January 24, 2022 Ultra Seal Corporation 301,842 bottles units

FDA Drug Class II Terminated

Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, N

January 24, 2022 Ultra Seal Corporation a) 9,060 bottles, b) 44,700 packets units

FDA Drug Class II Terminated

Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03

January 24, 2022 Ultra Seal Corporation 7,858,690 packets units

FDA Drug Class II Terminated

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040

January 24, 2022 Ultra Seal Corporation 3,508,200 packets units

FDA Drug Class II Terminated

Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

January 24, 2022 Ultra Seal Corporation 915,770 packets units

FDA Drug Class II Terminated

PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060

January 24, 2022 Ultra Seal Corporation a) 156,096 packets, b) 9,648 bottles units

FDA Drug Class II Terminated

DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03

January 24, 2022 Ultra Seal Corporation 2,685,700 packets units

FDA Drug Class II Terminated

PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060

January 24, 2022 Ultra Seal Corporation a) 113,040 packets, b) 7,132 bottles units

FDA Drug Class II Terminated

FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

January 24, 2022 Ultra Seal Corporation 223,090 packets units

FDA Drug Class II Terminated

Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 0

January 24, 2022 Ultra Seal Corporation 673,160 packets units

FDA Drug Class II Terminated

PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423

January 24, 2022 Ultra Seal Corporation 533,100 packets units

FDA Drug Class II Terminated

Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02

January 24, 2022 Ultra Seal Corporation 5,741,384 packets units

FDA Drug Class II Terminated

PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 922

January 24, 2022 Ultra Seal Corporation 1,188,280 packets units

FDA Drug Class II Terminated

Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Ma

January 24, 2022 Ultra Seal Corporation 1,186,000 packets units

FDA Drug Class II Terminated

Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

January 24, 2022 Ultra Seal Corporation 227,010 packets units

FDA Drug Class II Terminated

CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2

January 24, 2022 Ultra Seal Corporation 225,350 packets units

FDA Drug Class II Terminated

Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50

January 24, 2022 Ultra Seal Corporation 174,852 bottles units

FDA Drug Class II Terminated

Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

January 24, 2022 Ultra Seal Corporation 301,650 packets units

FDA Drug Class II Terminated

PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03

January 24, 2022 Ultra Seal Corporation 769,200 packets units

FDA Drug Class II Terminated

MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA

January 24, 2022 Ultra Seal Corporation 2,189,232 bottles units

FDA Drug Class II Terminated

Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

January 24, 2022 Ultra Seal Corporation 1,486,050 packets units

FDA Drug Class II Terminated

PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

January 24, 2022 Ultra Seal Corporation 2,336,600 packets units

FDA Drug Class II Terminated

CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

January 24, 2022 Ultra Seal Corporation 447,050 packets units

FDA Drug Class II Terminated

Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487

January 24, 2022 Ultra Seal Corporation 25,776 blisters units

FDA Drug Class II Terminated

DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution

January 24, 2022 Ultra Seal Corporation a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets units

FDA Drug Class II Terminated

CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

January 24, 2022 Ultra Seal Corporation 1,019,000 packets units

FDA Drug Class II Terminated

MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

January 24, 2022 Ultra Seal Corporation 409,890 packets units

FDA Drug Class II Terminated

Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68

January 24, 2022 Ultra Seal Corporation 1,309,800 packets units

FDA Drug Class II Terminated

Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road

January 24, 2022 Ultra Seal Corporation a) 702,240 blisters, b) 30,180 blisters units