NIGHTTIME SLEEP AID- diphenhydramine hcl tablet, film coated 
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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Equaline 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

  • in 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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • drowsiness will occur
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-877-932-7948

Principal Display Panel

compare to
Simply Sleep®

active ingredient*
NDC 41163-367-06

EQUALINE®

nighttime
sleep aid
diphenhydramine HCl 25 mg (nighttime sleep aid)

for a restful night's sleep
• safe, non-habit forming

DOES NOT CONTAIN PAIN RELIEVER

actual size

200 mini caplets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.
50844        REV0516D36706

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

100% Quality
GUARANTEED

Like it or let us make it right.
That's our quality promise.
877-932-7948
supervaluprivatebrands.com

Equaline 44-367

Equaline 44-367


NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-367
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 44;367
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-367-08 2 in 1 CARTON 06/10/2000
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:41163-367-06 1 in 1 CARTON 06/10/2000
2 200 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:41163-367-12 1 in 1 CARTON 06/10/2000
3 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 06/10/2000
Labeler - SUPERVALU INC. (006961411)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(41163-367)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(41163-367)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 PACK(41163-367)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 PACK(41163-367)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 PACK(41163-367)

Revised: 7/2017
Document Id: 75b31334-181f-4890-ba05-8080b165d809
Set id: 6c9b7576-428a-4884-8331-bb312c9046bd
Version: 6
Effective Time: 20170710
 
SUPERVALU INC.