Dormin Capsule
FDA Label NDC 52412-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Randob Labs,ltd. for the product Dormin (NDC 52412-100). 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, keep out of reach of children, uses, warnings, ask doctor, ask doctor/pharmacist, when using, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Diphenhydramine Hydrochloride

Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

  • ▪helps to reduce difficulty falling asleep

Warnings

  • ▪Do not use
  • ▪in children under 12 years of age
  • ▪with any other product containing diphenhydramine, even one used on skin

Ask Doctor

As a doctor before use if you have

  • ▪a breathing problem such as emphysema or chronic bronchitis
  • ▪glaucoma
  • ▪trouble urinating due to enlarged prostate gland

Ask Doctor/Pharmacist

As a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using

When using this product

  • ▪avoid alcoholic drinks

Stop Use

Stop use and ask a doctor if sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Pregnancy Or Breast Feeding

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

Directions

Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor

Children under 12 years of age: Do not give this product to children under 12 years of age

Other Information

  • ▪keep in dry place

    • Use by expiration date on pack

Inactive Ingredients

FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.

Principal Display Panel

Dormin®

THE NIGHTTIME SLEEP-AID

With Diphenhydramine Hydrochloride

  • FAST
  • SAFE
  • EFFECTIVE

    • 72 Capsules

    R:\edrls\drug Listing Images\dormin\container-label.jpg (Container Label)

    R:\edrls\drug Listing Images\dormin\container-label.jpg (Container Label)

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