Hy-Vee, Inc. Night Time Sleep Aid Drug Facts

Night Time Sleep Aid by

Drug Labeling and Warnings

Night Time Sleep Aid by is a Otc medication manufactured, distributed, or labeled by HyVee Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIGHT TIME SLEEP AID- diphenhydramine hcl solution 
HyVee Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hy-Vee, Inc. Night Time Sleep Aid Drug Facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
• with other Nighttime products

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

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.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• take only one dose per day (24 hours) – see Overdose warning
• use dose cup

• adults & children 12 yrs & over:

  30 mL at bed time if needed or as directed by a doctor

• children under 12 yrs:

  do not use

Other information

• each 30 mL dose cup contains: sodium 20 mg
• store at 20-25˚C (68-77˚F)
• protect from light. Does not meet USP <671>.

Inactive Ingredients

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO the Active Ingredient of Vicks® ZzzQuil®

Nighttime Sleep Aid

Diphenhydramine HCl 50 mg per 30 mL

Relieves Occasional Sleeplessness

#1 Doctor Recommended Active Ingredient

Not for Treating Cold or Flu

See Warnings

Non-Habit Forming

10% ALCOHOL

Berry Flavor

6 FL OZ (117 mL)

NIGHT TIME SLEEP AID 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-959
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE (clear)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-959-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2013	02/11/2019
2	NDC: 42507-959-34	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2013	06/16/2018
3	NDC: 42507-959-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2013	05/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	07/08/2013	05/21/2019

Labeler - HyVee Inc (006925671)

Revised: 11/2019

Document Id: bb3fa1fd-cf59-4467-bdcf-49ca648cb400

34390-5

Set id: cf94fa56-01a5-4d6c-ad08-38b0ea363399

Version: 5

Effective Time: 20191122

 

HyVee Inc