Diurex Ultra

Diurex Ultra
SPL v15
SPL
SPL Set ID 9a035265-40c6-43f5-8de6-6bece8449840
Route
ORAL
Published
Effective Date 2025-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ALVA Shape: round Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-09-01

Description

Caffeine Anhydrous, 100 mg

Purpose

Diuretic


Medication Information

Purpose

Diuretic

Description

Caffeine Anhydrous, 100 mg

Uses

For the relief of:

  • temporary water retention
  • bloating
  • swelling
  • full feeling
  • fatigue

associated with the pre-menstrual and menstrual periods

Section 42229-5

Section 50565-1

Keep out of the 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.

Warnings


Directions
  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults: One (1) pill (100 mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours wile symptoms persist, not to exceed 8 pills in a 24 hour period.
  • Drink 6 to 8 glasses of water daily.
  • Recommended for use by normally healthy adults only.
Other Information
  • Calcium content:  30 mg/pill
  • Identification:  Light green colored, round pill bearing the identifying mark "ALVA".
  • **Contents sealed:  Contents packaged in a bottle with a safety seal under the cap.  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, 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 the relief of:

  • temporary water retention
  • bloating
  • swelling
  • full feeling
  • fatigue

associated with the pre-menstrual and menstrual periods

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of the 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

Warnings


Directions
  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults: One (1) pill (100 mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours wile symptoms persist, not to exceed 8 pills in a 24 hour 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
  • Identification:  Light green colored, round pill bearing the identifying mark "ALVA".
  • **Contents sealed:  Contents packaged in a bottle with a safety seal under the cap.  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, 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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