Proctozone-b Tm

SPL v2

SPL

SPL Set ID c53ed934-3846-4dc8-b97b-c84171c21ae1

Route

RECTAL

Published

Effective Date 2024-10-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Deacetylbisacodyl (10 mg)

Inactive Ingredients

Fat, Hard

Identifiers & Packaging

Pill Appearance

Shape: bullet Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For rectal use only

Indications and Usage

Use

for relief of occasional constipation (irregularity)
this product generally produces bowel movement in 15 minutes to 1 hour

Dosage and Administration

Directions

adults and children

12 years of age and over

1 suppository in a single daily dose. Peel open plastic. Insert suppository

well into rectum, pointed end first. Retain about 15 to 20 minutes

children 6 to under 12 years

1/2 suppository in a single daily dose

children under 6 years

Do not use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

store at 20-25°C (68-77°F)
if suppository softens prior to use, may be placed in refrigerator for short time

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

you need to use a laxative product for longer than one week
you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.

Section 50567-7

When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

Section 50569-3

Ask a doctor before use if you have

stomach pain, nausea or vomiting
a sudden change in bowel habits that lasts more than 2 weeks

Section 51727-6

Inactive ingredient hard fat

Section 51945-4

NDC 57237-337-21 (3 blisters of 4 suppositories)

Proctozone-B^TM

Bisacodyl (USP) 10 mg Suppositories

MEDICATED LAXATIVE SUPPOSITORY

Gentle, Predictable Relief

DO NOT SWALLOW

NDC 57237-337-04 (4 suppositories in 1 blister pack)

Front Foil

NDC 57237-337-04 (4 suppositories in 1 blister pack)

Back Foil

Section 53413-1

Questions or Comments: Call 1-844-474-7464

Section 53414-9

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

Section 55105-1

Purpose

Stimulant Laxative

Section 55106-9

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

Section 60561-8

TAMPER EVIDENT, INDIVIVIDUALLY SEALED FOR YOUR PROTECTION

Structured Label Content

Indications and Usage (34067-9)

Use

for relief of occasional constipation (irregularity)
this product generally produces bowel movement in 15 minutes to 1 hour

Dosage and Administration (34068-7)

Directions

adults and children

12 years of age and over

1 suppository in a single daily dose. Peel open plastic. Insert suppository

well into rectum, pointed end first. Retain about 15 to 20 minutes

children 6 to under 12 years

1/2 suppository in a single daily dose

children under 6 years

Do not use

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

store at 20-25°C (68-77°F)
if suppository softens prior to use, may be placed in refrigerator for short time

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

you need to use a laxative product for longer than one week
you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

Section 50569-3 (50569-3)

Ask a doctor before use if you have

stomach pain, nausea or vomiting
a sudden change in bowel habits that lasts more than 2 weeks

Section 51727-6 (51727-6)

Inactive ingredient hard fat

Section 51945-4 (51945-4)

NDC 57237-337-21 (3 blisters of 4 suppositories)

Proctozone-B^TM

Bisacodyl (USP) 10 mg Suppositories

MEDICATED LAXATIVE SUPPOSITORY

Gentle, Predictable Relief

DO NOT SWALLOW

NDC 57237-337-04 (4 suppositories in 1 blister pack)

Front Foil

NDC 57237-337-04 (4 suppositories in 1 blister pack)

Back Foil

Section 53413-1 (53413-1)

Questions or Comments: Call 1-844-474-7464

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stimulant Laxative

Section 55106-9 (55106-9)

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

Section 60561-8 (60561-8)

TAMPER EVIDENT, INDIVIVIDUALLY SEALED FOR YOUR PROTECTION

Advanced Ingredient Data

[{"name": "DEACETYLBISACODYL", "unii": "R09078E41Y", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FAT, HARD", "unii": "8334LX7S21", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use for relief of occasional constipation (irregularity) this product generally produces bowel movement in 15 minutes to 1 hour", "34068-7": "Directions adults and children 12 years of age and over 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes children 6 to under 12 years 1/2 suppository in a single daily dose children under 6 years Do not use", "34071-1": "Warnings For rectal use only", "42229-5": "Drug Facts", "44425-7": "Other information store at 20-25°C (68-77°F) if suppository softens prior to use, may be placed in refrigerator for short time", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if you need to use a laxative product for longer than one week you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.", "50567-7": "When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps", "50569-3": "Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks", "51727-6": "Inactive ingredient hard fat", "51945-4": "NDC 57237-337-21 (3 blisters of 4 suppositories) Proctozone-B TM Bisacodyl (USP) 10 mg Suppositories MEDICATED LAXATIVE SUPPOSITORY Gentle, Predictable Relief DO NOT SWALLOW NDC 57237-337-04 (4 suppositories in 1 blister pack) Front Foil NDC 57237-337-04 (4 suppositories in 1 blister pack) Back Foil", "53413-1": "Questions or Comments: Call 1-844-474-7464", "53414-9": "If pregnant or breast-feeding, ask health professional before use.", "55105-1": "Purpose Stimulant Laxative", "55106-9": "Active ingredient (in each suppository) Bisacodyl USP, 10 mg", "60561-8": "TAMPER EVIDENT, INDIVIVIDUALLY SEALED FOR YOUR PROTECTION"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:34.395168 · Updated: 2026-03-14T23:05:25.370894