Diurex Capsules

Manufacturer: Alva-Amco Pharmacal Companies, Inc.
Effective date: 2024-05-15
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 21:02:32

Label at a glance#

ProductDiurex

Active ingredientPAMABROM

Label structure12 sections

Indications and uses

For the relief of temporary water weight gain bloating swelling full feeling associated with the premenstrual and menstrual periods

Dosage and administration

Read all package directions and warnings before use. Use only as directed. Adults: Take one (1) capsule after breakfast with a full glass of water. Dose may be repeated after six (6) hours, not to exceed four (4) capsules per day. Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period. Drink 6 to 8 glasses of water daily. For use by normally healthy adults on...

Contacts and useful links#

PhoneLabel contact1-800-792-2582

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Pamabrom, 50 mg

Purpose

OTC - PURPOSE SECTION

Diuretic

Uses

INDICATIONS & USAGE SECTION

For the relief of

temporary water weight gain
bloating
swelling
full feeling

associated with the premenstrual and menstrual periods

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other medication.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Read all package directions and warnings before use.
Use only as directed.
Adults: Take one (1) capsule after breakfast with a full glass of water. Dose may be repeated after six (6) hours, not to exceed four (4) capsules per day.
Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.
Drink 6 to 8 glasses of water daily.
For use by normally healthy adults only.
Persons under 18 years of age should use only as directed by a doctor.
Note: The appearance of golden-tinted urine, which may occur after taking Diurex Water Capsules, is a normal and temporary effect.

Other Information

INFORMATION FOR PATIENTS SECTION

**Contents sealed: Each Diurex capsule bears the identifying mark "ALVA" in red, contains white, blue and golden colored beads and is sealed closed with a blue band, then further sealed in a clear plastic blister with a foil backing. Do not use if seal appears broken or if contents do not match product description. You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butyl alcohol, citric acid, FDC Blue #1 Lake, FDC Red #40 Lake, gelatin, magnesium oxide, polysorbate, potassium sorbate, povidone, propylene glycol, riboflavin, shellac, sodium hydroxide, starch, sucrose and titanium dioxide.

OTC - QUESTIONS SECTION

Questions? 1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DiurexCapsulesPDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-325	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	8	Legacy NDC	20240517_ab10451e-ff87-4974-bec4-7ba19c5bbe65.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Pamabrom	ACTIVE INGREDIENT	UA8U0KJM72	3
Pamabrom	ACTIVE MOIETY	UA8U0KJM72	3
Butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	3
Citric acid	INACTIVE INGREDIENT	2968PHW8QP	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	3
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	3
Gelatin	INACTIVE INGREDIENT	2G86QN327L	3
Magnesium oxide	INACTIVE INGREDIENT	3A3U0GI71G	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
Potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	3
Povidone	INACTIVE INGREDIENT	FZ989GH94E	3
Propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	3
Riboflavin	INACTIVE INGREDIENT	TLM2976OFR	3
Shellac	INACTIVE INGREDIENT	46N107B71O	3
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	3
Sucrose	INACTIVE INGREDIENT	C151H8M554	3
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	3
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

Diurex
Pamabrom
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM OXIDE
POLYSORBATE 80
POTASSIUM SORBATE
POVIDONE
PROPYLENE GLYCOL
RIBOFLAVIN
SHELLAC
SODIUM HYDROXIDE
SUCROSE
BUTYL ALCOHOL
TITANIUM DIOXIDE
STARCH, CORN
BROMOTHEOPHYLLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52389-325	52389-325-01, 52389-325-42, 52389-325-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
MAGNESIUM OXIDE	3A3U0GI71G	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
POVIDONE	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
RIBOFLAVIN	TLM2976OFR	IACT
SHELLAC	46N107B71O	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SUCROSE	C151H8M554	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT
PAMABROM	UA8U0KJM72	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 13 · 769 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	POWDER / RESPIRATORY (INHALATION)	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBCUTANEOUS	1 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C Yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED / ORAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET / ORAL		10 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Povidone	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LOTION, AUGMENTED / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RESPIRATORY (INHALATION)	8 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
Magnesium oxide	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, EXTENDED RELEASE / ORAL		75 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Butyl alcohol	BUTYL ALCOHOL	8PJ61P6TS3	TABLET / ORAL	0.01 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SYSTEM / TOPICAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	TABLET / SUBLINGUAL		19 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
46559301-c7c5-5c1a-e063-6394a90a9a8e			ab10451e-ff87-4974-bec4-7ba19c5bbe65	2025-12-19	Warnings	Exact identifier spl set id: ab10451e-ff87-4974-bec4-7ba19c5bbe65

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.