Label: UNISHIELD PMS RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
- NDC Code(s): 49314-8238-0
- Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2024
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- 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
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PRINCIPAL DISPLAY PANEL
Unishield
PMS Relief
Menstrual Relief
80 caplets / 2 Caplets Per Packet
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine Maleate 15 mg
Pain Reliever, Diuretic, Antihistamine
Pull To Open
This Package is for Households Without Young Children.
• Reduces water-weight gain
• Relieves headaches, backaches and muscular aches and pains
Relieves Cramps and Bloating
Tamper Evident Unit Dose Packets
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INGREDIENTS AND APPEARANCE
UNISHIELD PMS RELIEF
acetaminophen, pamabrom, pyrilamine maleate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-8238 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 STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:49314-8238-0 40 in 1 BOX 09/26/2022 1 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 - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092)