Up and up nighttime sleep aid capsule, liquid filled

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

  • for relief of occasional sleeplessness

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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 Control Center right away (1-800-222-1222).

Directions

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

  • store at 20-25C (68-77F)

Inactive ingredients

edible ink*, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-888-547-7400

Ingredients and appearance - Product information

Up and up nighttime sleep aid capsule, liquid filled- Diphenhydramine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11673-713
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Polyethylene glycol ( UNII: 3WJQ0SDW1A)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Color BLUE (clear to light blue) Size 13 mm
Shape OVAL Score 1
Imprint Code 5V6

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part338 USA

Labeler - Target Corporation( 006961700)

Package/label principal display panel

Compare to active ingredient in Unisom® SleepGels®

nighttime sleep-aid

diphenhydramine HCl, 50 mg

non-habit forming

60 SOFTGELS

ACTUAL SIZE

60 SOFTGELS