Topwin Speedy Enema
FDA Label NDC 73513-323

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Health Chemical Pharmaceutical Co., Ltd for the product Topwin Speedy Enema (NDC 73513-323). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before using any laxative if you have, stop using and ask a doctor if you have, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Glycerin  3g       

Purpose

Glycerin     Hyperosmotic Laxative

Uses

For relief of occasional constipation

Warnings

For rectal use only

Do Not Use

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

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

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

Keep Out Of Reach Of Children

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

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.

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

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

Topwin Speedy Enema  Ndc 73513-323-20

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Image Description (Carton)

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