OTC Medication Information: Sleep Aid

SLEEP AID- diphenhydramine hydrochloride tablet, film coated
Rite Aid Corporation

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.

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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

Warnings

Do not use

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

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep aid.

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • use caution when driving a motor vehicle or operating machinery

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

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use

Other information

  • each caplet contains: calcium 70 mg
  • avoid excessive heat (greater than 100ºF) or humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

RITE
AID
PHARMACY®

*Compare to the active ingredient in VICKS® ZzzQuil™

sleep aid
diphenhydramine HCl 25
nighttime sleep-aid

non-habit forming
not for treating
cold or flu

200
CAPLETS Actual Size

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

DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark VICKS® ZzzQuil™.

50844 ORG021567206

SATISFACTION
RITE AID®
GUARANTEE

IF YOU’RE NOT SATISFIED, WE’LL HAPPILY REFUND YOUR MONEY.

Rite Aid 44-672
(click image for full-size original)

Rite Aid 44-672

SLEEP AID
diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0672
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 27
FD&C BLUE NO. 2
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 44;672
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-0672-6 200 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 07/24/2015
Labeler — Rite Aid Corporation (014578892)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (11822-0672)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 PACK (11822-0672)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (11822-0672)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 MANUFACTURE (11822-0672), PACK (11822-0672)

Revised: 03/2020 Rite Aid Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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