EQUALINE NIGHT TIME SLEEP AID- diphenhydramine hcl solution 
Supervalu 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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SuperValu Inc. NightTime SleepAid Drug Facts

Active ingredient (in each 30 mL)

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

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

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

take only one dose per day (24 hours)
only use the dose cup provided

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 contains: sodium 20 mg
store at 20-25˚C (68-77˚F)

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?

1-877-932-7948

Package/Label Principal Display Panel

compare to Vicks® ZzzQuil® active ingredient

nighttime

sleep aid

diphenhydramine HCl

50mg per 30mL

#1 doctor recommended sleep-aid active ingredient

non-habit forming

NOT FOR TREATING COLD OR FLU

berry flavor

ALCOHOL 10%

6 FL OZ (177mL)

nighttime sleep aid image
EQUALINE NIGHT TIME SLEEP AID 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-186
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-186-30177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/2013
2NDC:41163-186-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33806/28/2013
Labeler - Supervalu Inc (006961411)

Revised: 11/2017
Document Id: f62beb95-4b75-4c1a-b73b-ba35f505d29b
Set id: 6d34ee3e-3d61-481e-98d6-acfa066e4247
Version: 3
Effective Time: 20171129
 
Supervalu Inc