Midol Boat Relief Ui1614837

Midol Boat Relief Ui1614837
SPL v3
SPL
SPL Set ID c1ad6073-63f6-669f-e053-2995a90aacee
Route
ORAL
Published
Effective Date 2021-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bromotheophylline (50 mg)
Inactive Ingredients
Talc Croscarmellose Sodium Hypromelloses Microcrystalline Cellulose Stearic Acid Titanium Dioxide Polyethylene Glycol, Unspecified Mineral Oil Sodium Lauryl Sulfate Magnesium Stearate Dibasic Calcium Phosphate Dihydrate

Identifiers & Packaging

Pill Appearance
Imprint: M Shape: oval Color: white Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses for the temporary relief of:

• bloating

• water-weight gain

• swelling

• full feeling associated with the premenstrual and menstrual periods

Dosage and 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
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50570-1

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

Section 51727-6

Inactive ingredients

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

Section 53413-1

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

Section 53414-9

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

Section 55106-9

Active ingredient (in each caplet) Purpose

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

Section 60561-8

Other information

  • Store between 20°-25°C (68°-77°F).
  • Each caplet contains: 160 mg of Calcium
Carton 60 Count

NEW

Midol®

Bloat Rlief

Pamabrom/Diuretic

RELIEVES BLOATING

SWELLING - FULL FEELING

WATER WEIGHT GAIN

60 CAPLETS


Structured Label Content

Indications and Usage (34067-9)

Uses for the temporary relief of:

• bloating

• water-weight gain

• swelling

• full feeling associated with the premenstrual and menstrual periods

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Active ingredient (in each caplet) Purpose

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

Section 60561-8 (60561-8)

Other information

  • Store between 20°-25°C (68°-77°F).
  • Each caplet contains: 160 mg of Calcium
Carton 60 Count (Carton 60 count)

NEW

Midol®

Bloat Rlief

Pamabrom/Diuretic

RELIEVES BLOATING

SWELLING - FULL FEELING

WATER WEIGHT GAIN

60 CAPLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)