Health Chemical Pharmaceutical Co., Ltd

Health Chemical Pharmaceutical Co., Ltd
SPL v32876
SPL
SPL Set ID 3ba8c3d2-1780-42e1-bec5-8f98771d475e
Route
RECTAL
Published
Effective Date 2023-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (3 g)
Inactive Ingredients
Methylparaben Sodium Chloride Sodium Benzoate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-28

Description

Glycerin  3g       

Purpose

Glycerin     Hyperosmotic Laxative


Medication Information

Purpose

Glycerin     Hyperosmotic Laxative

Description

Glycerin  3g       

Uses

For relief of occasional constipation

Warnings

For rectal use only

Directions
  • Single Daily Usage (per 24 hours)
  • Adults and children, 6 years and over: 20 ml / 3g Glycerin or as directed by a doctor
  • Children 3-6 years: 10 ml / 1.5g Glycerin or as directed by a doctor
  • Knee-chest / Upright position: Lubricate anus with petroleum jelly first, gently insert tip of the enema applicator into the rectum with a single side to side movement to prevent damage to the rectal wall, allow 15 minutes to 1 hour to produce bowel movement. Discard unit after use. No left fluid should be re-used.

Do Not Use

when rectal irritation, abdominal pain, nausea, fever, or vomiting are present unless directed by a doctor.

Questions?

Manufactured by Health Chemical Pharmaceutical Co, Ltd

Made in Taiwan

U.S. Importer: Larkin Inc. dba Asia Company

1695 Jerrold Avenue, San Francisco, CA 94124

Email: [email protected]

Phone: (415)285-8888

Active Ingredient

Glycerin  3g       

Other Information

Store below 77°F (25 °C) in a cool dry place and protected from sunlight. Do not use if cap is broken.

Inactive Ingredients

Methylparaben, Sodium Chloride, Sodium Benzoate, Water

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Topwin Speedy Enema  Ndc 73513 323 20

Stop Using and Ask A Doctor If You Have
  • rectal discomfort
  • burning sensation
  • rectal bleeding
  • no bowel movement within 1 hour of using this product
Ask A Doctor Before Using Any Laxative If You Have
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Structured Label Content

Uses

For relief of occasional constipation

Purpose

Glycerin     Hyperosmotic Laxative

Warnings

For rectal use only

Directions
  • Single Daily Usage (per 24 hours)
  • Adults and children, 6 years and over: 20 ml / 3g Glycerin or as directed by a doctor
  • Children 3-6 years: 10 ml / 1.5g Glycerin or as directed by a doctor
  • Knee-chest / Upright position: Lubricate anus with petroleum jelly first, gently insert tip of the enema applicator into the rectum with a single side to side movement to prevent damage to the rectal wall, allow 15 minutes to 1 hour to produce bowel movement. Discard unit after use. No left fluid should be re-used.

Do Not Use (Do not use)

when rectal irritation, abdominal pain, nausea, fever, or vomiting are present unless directed by a doctor.

Questions?

Manufactured by Health Chemical Pharmaceutical Co, Ltd

Made in Taiwan

U.S. Importer: Larkin Inc. dba Asia Company

1695 Jerrold Avenue, San Francisco, CA 94124

Email: [email protected]

Phone: (415)285-8888

Active Ingredient

Glycerin  3g       

Other Information

Store below 77°F (25 °C) in a cool dry place and protected from sunlight. Do not use if cap is broken.

Inactive Ingredients

Methylparaben, Sodium Chloride, Sodium Benzoate, Water

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

If swallowed, get medical help or contact a Poison Control Center right away.

Topwin Speedy Enema  Ndc 73513 323 20 (Topwin Speedy Enema  NDC 73513-323-20)

Stop Using and Ask A Doctor If You Have (Stop using and ask a doctor if you have)
  • rectal discomfort
  • burning sensation
  • rectal bleeding
  • no bowel movement within 1 hour of using this product
Ask A Doctor Before Using Any Laxative If You Have (Ask a doctor before using any laxative if you have)
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Advanced Ingredient Data


Raw Label Data

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