Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID eb35c241-29ef-4be7-9b07-039a059017dc
Route
RECTAL
Published
Effective Date 2019-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (12.5 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1992-07-05

Description

Glycerin- 12.5g


Medication Information

Description

Glycerin- 12.5g

Packaging

Warnings:

Do not use laxative products when abdominal

pain, nausea, or vomiting are present unless

directed by a doctor.

- If you have noticed a sudden change in bowel

habits that persists over a period of 2 weeks,

consult a doctor before using a laxative.

- Laxative products should not be used for a

period longer than 1 week unless directed by

a doctor.

- Rectal bleeding or failure to have a bowel

movement after use of a laxative may indicate

a serious condition. Discontinue use and

consult your doctor.

- May cause rectal discomfort or a burning

sensation.

- For rectal use only.

使用前請先諮詢醫生如果您有以下症狀:

腹痛,噁心,嘔吐,突然改變排便習慣持

續2週以上. 如使用後直腸出血或無效,病

情嚴重應該停止使用,並諮詢你的醫生。

僅作為直腸用藥

Directions:

Adults and children 12 years of age and

older: 1 bottle each time, 1 time per day.

成人和 12 歲以上的兒童: 每次1瓶,每日1次

children 6 to under 12 years: use ½ bottle

each time, 1 time per day.

兒童6〜12歲:每次使用1/2瓶,每天1次,

children under 6 years: ask a doctor

6歲以下兒童:問醫生

Removing the top, Coated with grease

and Slowly inserted into the anus Then

squeeze the liquid into the rectum.

除去頂端膠塞, 涂以油脂少許, 緩慢插入肛門, 然

後將藥液擠入直腸內.

Do Not Use:

If pregnant or breast-feeding.

ask a health professional before use.

如果懷孕或哺乳。使用前請諮詢專業醫師。

Indications

For relief of occasional constipation

(irregularity)

減輕偶發性便秘(不規則)

This product generally produces bowel

movement in 1/4 to 1 hour.

通常產生作用的時間在15分鐘至60分鐘內.

Active Ingredients

Glycerin- 12.5g

Inactive Ingredients

Purified water 純淨水

When Using This Product:

you may have rectal discomfort or a burning sensation

使用本產品時,你可能有直腸不適或燒灼感

Stop Use and Ask Doctor If:

you have rectal bleeding

停止使用並諮詢醫生 n如果你有排便出血

Keep Out of Reach of Children

In case of accidental ingestion, contact doctor or a poision control center immediately


Structured Label Content

Packaging

Warnings:

Do not use laxative products when abdominal

pain, nausea, or vomiting are present unless

directed by a doctor.

- If you have noticed a sudden change in bowel

habits that persists over a period of 2 weeks,

consult a doctor before using a laxative.

- Laxative products should not be used for a

period longer than 1 week unless directed by

a doctor.

- Rectal bleeding or failure to have a bowel

movement after use of a laxative may indicate

a serious condition. Discontinue use and

consult your doctor.

- May cause rectal discomfort or a burning

sensation.

- For rectal use only.

使用前請先諮詢醫生如果您有以下症狀:

腹痛,噁心,嘔吐,突然改變排便習慣持

續2週以上. 如使用後直腸出血或無效,病

情嚴重應該停止使用,並諮詢你的醫生。

僅作為直腸用藥

Directions:

Adults and children 12 years of age and

older: 1 bottle each time, 1 time per day.

成人和 12 歲以上的兒童: 每次1瓶,每日1次

children 6 to under 12 years: use ½ bottle

each time, 1 time per day.

兒童6〜12歲:每次使用1/2瓶,每天1次,

children under 6 years: ask a doctor

6歲以下兒童:問醫生

Removing the top, Coated with grease

and Slowly inserted into the anus Then

squeeze the liquid into the rectum.

除去頂端膠塞, 涂以油脂少許, 緩慢插入肛門, 然

後將藥液擠入直腸內.

Do Not Use: (Do not use:)

If pregnant or breast-feeding.

ask a health professional before use.

如果懷孕或哺乳。使用前請諮詢專業醫師。

Indications

For relief of occasional constipation

(irregularity)

減輕偶發性便秘(不規則)

This product generally produces bowel

movement in 1/4 to 1 hour.

通常產生作用的時間在15分鐘至60分鐘內.

Active Ingredients

Glycerin- 12.5g

Inactive Ingredients

Purified water 純淨水

When Using This Product: (When using this product:)

you may have rectal discomfort or a burning sensation

使用本產品時,你可能有直腸不適或燒灼感

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

you have rectal bleeding

停止使用並諮詢醫生 n如果你有排便出血

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, contact doctor or a poision control center immediately


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