Diurex Xpl

Diurex Xpl
SPL v11
SPL
SPL Set ID 9f971b95-47f4-4bd4-beec-2296b4c9cbdc
Route
ORAL
Published
Effective Date 2017-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (100 mg)
Inactive Ingredients
Calcium Carbonate Croscarmellose Sodium Ethyl Vanillin D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Blue No. 2 Acacia Hypromelloses Talc Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Polyethylene Glycol 400 Polysorbate 80 Stearic Acid Titanium Dioxide Anhydrous Lactose

Identifiers & Packaging

Pill Appearance
Imprint: ALVA Shape: round Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-08-17 Until 2026-05-31

Description

Caffeine Anhydrous, 100 mg

Purpose

Diuretic


Medication Information

Purpose

Diuretic

Description

Caffeine Anhydrous, 100 mg

Uses

For relief of symptoms associated with the premenstrual and menstrual periods including:

  • temporary water retention
  • bloat
  • swelling
  • full feeling
  • fatigue
Section 42229-5

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 50566-9

Stop use and ask a doctor if symptoms last for more than ten consecutive days.

Section 50567-7

When using this product, limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause:

  • nervousness
  • irritability
  • sleeplessness
  • occasional rapid heart beat. The recommended dose of this product contains about as much caffeine as one to two cups of coffee.
Section 51945-4

Section 53413-1

Questions? 1-800-792-2582

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Directions
  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults:  One (1) pill (100mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours while symptoms persist, not to exceed 8 pills in a 24 hour period.
  • Start taking 5 or 6 days before onset of period and continue use until desired relief is obtained or end of period.
  • Drink 6 to 8 glasses of water daily.
  • Recommended for use by normally healthy adults only.
Other Information
  • Calcium content:  30 mg/pill
  • **Contents sealed:  Each DIUREX light green colored, round shaped pill bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a foil backing. Do not use if seal appears broken or if product contents do not match product description.
  • You may report serious side effects to the phone number provided under Questions? below.
Inactive Ingredients

Acacia, calcium carbonate, croscarmellose sodium, D&C Yellow No. 10 Lake, ethyl vanillin, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate, stearic acid and titanium dioxide.

Ask A Doctor Before Use If
  • taking any other medications
  • under 18 years of age.  Do not give to children under 12 years of age.
Active Ingredient (in Each Pill)

Caffeine Anhydrous, 100 mg


Structured Label Content

Uses

For relief of symptoms associated with the premenstrual and menstrual periods including:

  • temporary water retention
  • bloat
  • swelling
  • full feeling
  • fatigue
Section 42229-5 (42229-5)

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 50566-9 (50566-9)

Stop use and ask a doctor if symptoms last for more than ten consecutive days.

Section 50567-7 (50567-7)

When using this product, limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause:

  • nervousness
  • irritability
  • sleeplessness
  • occasional rapid heart beat. The recommended dose of this product contains about as much caffeine as one to two cups of coffee.
Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-792-2582

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Diuretic

Directions
  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults:  One (1) pill (100mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours while symptoms persist, not to exceed 8 pills in a 24 hour period.
  • Start taking 5 or 6 days before onset of period and continue use until desired relief is obtained or end of period.
  • Drink 6 to 8 glasses of water daily.
  • Recommended for use by normally healthy adults only.
Other Information (Other information)
  • Calcium content:  30 mg/pill
  • **Contents sealed:  Each DIUREX light green colored, round shaped pill bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a foil backing. Do not use if seal appears broken or if product contents do not match product description.
  • You may report serious side effects to the phone number provided under Questions? below.
Inactive Ingredients (Inactive ingredients)

Acacia, calcium carbonate, croscarmellose sodium, D&C Yellow No. 10 Lake, ethyl vanillin, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate, stearic acid and titanium dioxide.

Ask A Doctor Before Use If (Ask a doctor before use if)
  • taking any other medications
  • under 18 years of age.  Do not give to children under 12 years of age.
Active Ingredient (in Each Pill) (Active ingredient (in each pill))

Caffeine Anhydrous, 100 mg


Advanced Ingredient Data


Raw Label Data

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