0406-9914 : Restoril 22.5 mg Oral Capsule

NDC:	0406-9914
Labeler:	Mallinckrodt, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Restoril
Dosage Form:	Oral Capsule
Application #:	NDA018163
Rev. Date:	Jul 7, 2011
CSA Schedule:	CIV (US) [1]

^[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	FOR;SLEEP;M;RESTORIL;22;5;mg
Shapes:	Capsule
Colors:	Blue
Size (mm):	16
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 0406-9914-03: 30 CAPSULE IN 1 BOTTLE (0406‑9914‑03)

Active Ingredients:

• Temazepam

Inactive Ingredients:

• Alcohol
• Aluminum Oxide
• Butyl Alcohol
• Ethyl Acetate
• Ferric Oxide Red
• Fd&c Blue No. 1
• Fd&c Red No. 3
• Gelatin
• Isopropyl Alcohol
• Lactose
• Magnesium Stearate
• Propylene Glycol
• Shellac
• Titanium Dioxide

Pharmaceutical Classes:

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

Related Products:

Based on records with the same trade name.

• 0406-9915 Restoril 7.5 mg Oral Capsule by Mallinckrodt, Inc.
• 0406-9916 Restoril 15 mg Oral Capsule by Mallinckrodt, Inc.
• 0406-9917 Restoril 30 mg Oral Capsule by Mallinckrodt, Inc.
• 54868-0778 Restoril 15 mg Oral Capsule by Physicians Total Care, Inc.
• 54868-3657 Restoril 7.5 mg Oral Capsule by Physicians Total Care, Inc.
• 55154-7257 Restoril 7.5 mg Oral Capsule by Cardinal Health

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