Label: GREEN GUARD CRAMP RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
- NDC Code(s): 47682-049-47, 47682-049-80, 47682-049-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 19, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnigs
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
Menstrual Cramp Relief™
Pull to Open
Tire Para Abrir
Acetaminophen 500 mg / Acetaminofeno 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg / Maleato de pirilamina 15 mg
Green Guard®
Relief of menstrual pain, water retention and bloating
Para el alivio de dolores menstruales,
retencion de liquidos e hinchazon
40 Packets of 2 Caplets
80 Caplets
Order #2380
Distributed by Green Guard®
St Louis, MO 63045
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INGREDIENTS AND APPEARANCE
GREEN GUARD CRAMP RELIEF
acetaminophen, pamabrom, pyrilamine maleate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-049 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SHELLAC (UNII: 46N107B71O) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) 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:47682-049-80 40 in 1 BOX 09/26/2022 1 NDC:47682-049-99 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-049-47 100 in 1 BOX 09/26/2022 2 NDC:47682-049-99 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 Labeler - Unifirst First Aid Corporation (832947092)