MIDOL BLOAT RELIEF- pamabrom tablet

Midol Bloat Relief by

Drug Labeling and Warnings

Midol Bloat Relief by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet) Purpose

Pamabrom 50 mg……….……………………………………….…...Diuretic

PURPOSE

INDICATIONS & USAGE

Uses for the temporary relief of:

bloating

water-weight gain

swelling

full feeling associated with the premenstrual and menstrual periods

WARNINGS

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• do not take more than the recommended dose
• adults and children 12 years and older:
  • take 1 caplet with water
  • repeat every 6 hours, as needed
  • do not exceed 4 caplets per day
• children under 12 years: consult a doctor

OTHER SAFETY INFORMATION

Other information

• Store between 20°-25°C (68°-77°F).
• Each caplet contains: 160 mg of Calcium

INACTIVE INGREDIENT

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium lauryl sulfate, stearic acid, talc, titanium dioxide

QUESTIONS

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

Carton 60 count

NEW

Midol®

Bloat Rlief

Pamabrom/Diuretic

RELIEVES BLOATING

SWELLING - FULL FEELING

WATER WEIGHT GAIN

60 CAPLETS

INGREDIENTS AND APPEARANCE

MIDOL BLOAT RELIEF 
pamabrom tablet

Product 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)