DIUREX ULTRA- caffeine tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Alva-Amco Pharmacal Companies, Inc.
INN (International Name):
Caffeine
Composition:
Caffeine 100 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Diuretic For the relief of: - temporary water retention - bloating - swelling - full feeling - fatigue associated with the pre-menstrual and menstrual periods - taking any other medications - under 18 years of age.  Do not give to children under 12 years of age. Stop use and ask a doctor if symptoms last for more than ten consecutive days.
Authorization status:
unapproved drug other
Authorization number:
52389-155-80

DIUREX ULTRA- caffeine tablet, film coated

Alva-Amco Pharmacal Companies, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Diurex Ultra

Active ingredient (in each pill)

Caffeine Anhydrous, 100 mg

Purpos e

Diuretic

Us es

For the relief of:

temporary water retention

bloating

swelling

full feeling

fatigue

associated with the pre-menstrual and menstrual periods

Warnings

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.

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.

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

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

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

Center right away.

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.

Questions? 1-800-792-2582

DIUREX ULTRA

caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5238 9 -155

Route of Administration

ORAL

Alva-Amco Pharmacal Companies, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACACIA (UNII: 5C540 3N26 O)

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ETHYL VANILLIN (UNII: YC9 ST449 YJ)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TALC (UNII: 7SEV7J4R1U)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

Product Characteristics

Color

green (light green)

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

ALVA

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:5238 9 -155-

8 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 9 /0 1/20 0 5

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /0 1/20 0 5

Labeler -

Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 4/2019

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