Label: MIDOL BLOAT RELIEF- pamabrom tablet
- NDC Code(s): 0280-0070-01
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 1, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Carton 60 count
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INGREDIENTS AND APPEARANCE
MIDOL BLOAT RELIEF
pamabrom tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0070 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 50 mg Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MINERAL OIL (UNII: T5L8T28FGP) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MAGNESIUM STEARATE (UNII: 70097M6I30) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Product Characteristics Color white Score no score Shape OVAL Size 9mm Flavor Imprint Code M Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0070-01 1 in 1 CARTON 04/28/2021 1 60 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M027 04/28/2021 Labeler - Bayer HealthCare LLC. (112117283)