OTC Medication Information: Sleep Aid

SLEEP AID- diphenhydramine hydrochloride liquid
Harmon Store 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.

Active ingredient
(in each 30 mL dose cup)

Diphenhydramine HCl 50 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

  • 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 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 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
  • mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: take 30 mL (2 TBSP) in the dosing cup provided at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information

  • each 30 mL dose cup contains: sodium 17 mg
  • store at 25ºC (77Fº); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions or comments?

1-800-426-9391

Principal display panel

CORE VALUES™

Compare to the active ingredient in Vicks® ZzzQuil® NIGHTTIME SLEEP-AID †

Nightime
Sleep Aid
Diphenhydramine HCl /
Nighttime Sleep Aid

• Non-habit forming
• Alcohol free

12 FL OZ (355 mL) berry flavor

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark VICKS® ZzzQuil® NIGHTTIME SLEEP-AID.

50844 ORG101700202

Distributed by: Liberty Procurement Co. Inc.
650 Liberty Ave., Union, NJ 07083 U.S.A
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Core Values 44-002A
(click image for full-size original)

Core Values 44-002A

SLEEP AID
diphenhydramine hcl liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
SUCRALOSE
SUCROSE
XANTHAN GUM
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color PURPLE Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63940-200-02 355 mL in 1 BOTTLE, PLASTIC None
2 NDC:63940-200-45 177 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 10/01/2018
Labeler — Harmon Store Inc. (804085293)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 MANUFACTURE (63940-200), PACK (63940-200)

Revised: 09/2019 Harmon Store Inc.

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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