Label: MEDI FIRST PMS RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, coated
MEDI FIRST PLUS PMS RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, coated
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NDC Code(s):
47682-723-36,
47682-723-80,
47682-823-36,
47682-823-80, view more47682-823-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
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.
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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PRINCIPAL DISPLAY PANEL
Medi-First®Plus
PMS Relief
Pain Reliever • Acetaminophen 500 mg
Diuretic • Pamabrom 25 mg
Antihistamine • Pyrilamine maleate 15 mg
This Package is for Households Without Young Children.
Pull to Open
Relief from Menstrual Pain, Water Retention and Bloating
Tamper Evident Unit Dose Packets
80 Caplets
(40 x 2's)
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INGREDIENTS AND APPEARANCE
MEDI FIRST PMS RELIEF
acetaminophen, pamabrom, pyrilamine maleate tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-823 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) CROSPOVIDONE (UNII: 2S7830E561) STEARIC ACID (UNII: 4ELV7Z65AP) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color purple Score no score Shape CAPSULE (Caplet) Size 17mm Flavor Imprint Code 44;679 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-823-80 40 in 1 BOX 09/26/2022 1 NDC:47682-823-99 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-823-36 75 in 1 BOX 02/01/2023 2 NDC:47682-823-99 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M027 09/26/2022 MEDI FIRST PLUS PMS RELIEF
acetaminophen, pamabrom, pyrilamine maleate tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-723 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) CROSPOVIDONE (UNII: 2S7830E561) STEARIC ACID (UNII: 4ELV7Z65AP) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color purple Score no score Shape CAPSULE (Caplet) Size 17mm Flavor Imprint Code 44;679 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-723-80 40 in 1 BOX 09/26/2022 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-723-36 75 in 1 BOX 02/01/2023 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M027 09/26/2022 Labeler - Unifirst First Aid Corporation (832947092)