Rugby® - DailyMed Details

Rugby®

SPL v6

SPL

SPL Set ID ce47c06f-c6c9-436f-83d0-7ea329cd145d

Route

RECTAL

Published

Effective Date 2025-09-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Sodium Cation (7 g)

Inactive Ingredients

Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2011-09-01 Until 2026-03-31

Description

Drug Facts

Medication Information

Description

Drug Facts

Use

▪
relieves occasional constipation
▪
this product generally produces bowel movement in 1 to 5 minutes

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 53414-9

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

Section 55105-1

Active ingredients (in each 118mL delivered dose)	Purpose
Dibasic Sodium Phosphate 7 g	Saline laxative
Monobasic Sodium Phosphate 19 g	Saline laxative

Do Not Use

▪
on children under 2 years of age

Dosage Warning

Using more than one enema in 24 hours can be harmful.

For rectal use only.

Other Information

▪
each 118 ml contains sodium 4.3 g
▪
store at 15 to 30°C (59 to 86°F)
▪
additional liquids by mouth are recommended while using this product
▪
Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

866-323-0107

When Using This Product

▪
do not use more than directed. Serious side effects may occur from excess dosage
▪
do not use for more than 3 days, without asking a doctor

Stop Use and Ask A Doctor If

▪
you have rectal bleeding
▪
you have no bowel movement within 30 minutes of enema use
▪
you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

Ask A Doctor Before Use If You

▪
have already used a laxative for more than 3 days
▪
have kidney disease, have heart problems, or are dehydrated
▪
are 55 years of age or older
▪
are on a sodium-restricted diet
▪
have abdominal pain, nausea, or vomiting
▪
have a sudden change in bowel habits lasting more than 2 weeks

Directions (or As Directed By A Doctor)

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years of age and older	1 bottle once daily
Children 2 to under 12 years of age	Use Pediatric Enema
Children under 2 years of age	DO NOT USE

Principal Display Panel 133 Ml Bottle Carton

Rugby^®

NDC 0536-7415-51

Compare to the

active ingredients of

Fleet^® Saline Enema*

Ready-to-Use

Enema

Saline Laxative

For relief of occasional

constipation

Not made with natural

rubber latex

4.5 FL OZ (133 mL)

1 Bottle

Structured Label Content

Use

▪
relieves occasional constipation
▪
this product generally produces bowel movement in 1 to 5 minutes

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each 118mL delivered dose)	Purpose
Dibasic Sodium Phosphate 7 g	Saline laxative
Monobasic Sodium Phosphate 19 g	Saline laxative

Do Not Use (Do not use)

▪
on children under 2 years of age

Dosage Warning (Dosage warning)

Using more than one enema in 24 hours can be harmful.

For rectal use only.

Other Information (Other information)

▪
each 118 ml contains sodium 4.3 g
▪
store at 15 to 30°C (59 to 86°F)
▪
additional liquids by mouth are recommended while using this product
▪
Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments? (Questions or comments?)

866-323-0107

When Using This Product (When using this product)

▪
do not use more than directed. Serious side effects may occur from excess dosage
▪
do not use for more than 3 days, without asking a doctor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

▪
you have rectal bleeding
▪
you have no bowel movement within 30 minutes of enema use
▪
you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

Ask A Doctor Before Use If You (Ask a doctor before use if you)

▪
have already used a laxative for more than 3 days
▪
have kidney disease, have heart problems, or are dehydrated
▪
are 55 years of age or older
▪
are on a sodium-restricted diet
▪
have abdominal pain, nausea, or vomiting
▪
have a sudden change in bowel habits lasting more than 2 weeks

Directions (or As Directed By A Doctor) (Directions (or as directed by a doctor))

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years of age and older	1 bottle once daily
Children 2 to under 12 years of age	Use Pediatric Enema
Children under 2 years of age	DO NOT USE

Principal Display Panel 133 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton)

Rugby^®

NDC 0536-7415-51

Compare to the

active ingredients of

Fleet^® Saline Enema*

Ready-to-Use

Enema

Saline Laxative

For relief of occasional

constipation

Not made with natural

rubber latex

4.5 FL OZ (133 mL)

1 Bottle

Advanced Ingredient Data

[{"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "118", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "19", "strengthDenominator": "118", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "▪ relieves occasional constipation ▪ this product generally produces bowel movement in 1 to 5 minutes", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.", "50568-5": "Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative", "Do not use": "▪ on children under 2 years of age", "Dosage warning": "Using more than one enema in 24 hours can be harmful. For rectal use only.", "Other information": "▪ each 118 ml contains sodium 4.3 g ▪ store at 15 to 30°C (59 to 86°F) ▪ additional liquids by mouth are recommended while using this product ▪ Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.", "Inactive ingredients": "benzalkonium chloride, disodium EDTA, purified water", "Questions or comments?": "866-323-0107", "When using this product": "▪ do not use more than directed. Serious side effects may occur from excess dosage ▪ do not use for more than 3 days, without asking a doctor", "Stop use and ask a doctor if": "▪ you have rectal bleeding ▪ you have no bowel movement within 30 minutes of enema use ▪ you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.", "Ask a doctor before use if you": "▪ have already used a laxative for more than 3 days ▪ have kidney disease, have heart problems, or are dehydrated ▪ are 55 years of age or older ▪ are on a sodium-restricted diet ▪ have abdominal pain, nausea, or vomiting ▪ have a sudden change in bowel habits lasting more than 2 weeks", "Directions (or as directed by a doctor)": "Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings . Adults and children 12 years of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age DO NOT USE", "PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton": "Rugby ® NDC 0536-7415-51 Compare to the active ingredients of Fleet ® Saline Enema* Ready-to-Use Enema Saline Laxative For relief of occasional constipation Not made with natural rubber latex 4.5 FL OZ (133 mL) 1 Bottle"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:05.843389 · Updated: 2026-03-14T23:10:18.112618