Byun Rak
FDA Label NDC 72689-0043

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oasis Trading for the product Byun Rak (NDC 72689-0043). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

■relieves occasional constipation(Irregularity)
■generally produces bowel movement in 6 to 12 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

■ adult and children 15 years of age and older: 1envelop twice daily
■ children 11 to under 15 years of age: 2/3 envelop twice daily
■ children 7 to under 11 years of age: 1/2 envelop twice daily
■ children 3 to under 7 years of age: 1/3 envelop twice daily
■ children under 3 years of age: ask a doctor

Warnings

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks
When using this product
Do not use for a period longer than 1 weeks
Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use.
keep out of reach of children. In case of overdose, get medical help or contact a poison contral center right away.

Inactive Ingredient

corn starch, Sodium Carboxymethyl Cellulose

Dosage & Administration

For oral use only

Package Label.Principal Display Panel

1 (12121)

1 (12121)

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