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
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 25, 2022
If you are a consumer or patient please visit this version.
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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 not final part343 09/26/2022 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092)