SLEEP AID- diphenhydramine hcl capsule, liquid filled

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use(s)

• 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
  

Ask a doctor before use if

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

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
• be careful when driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

if sleeplessness persists continuously for more than 2 weeks.

•  Insomnia may be a symptom of serious underlying medical illness.
  

Pregnancy/Breastfeeding

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 (1-800-222-1222) right away.

Directions

take only one dose per day (24 hours) - see Overdose warning

Adults and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Other information

Do not use if blister unit is torn or open.

Do not use if imprinted safety seal under cap is broken or missing.

Storage

• store at 15-30° C (59-86° F)
• avoid excessive heat above 40° C (104° F) and high humidity
• Protect from light 
  

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, white edible ink

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Principal Display Panel

Sleep Aid 96ct

Sleep Aid 12ct

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-431
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	PC11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-431-96	96 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2021
2	NDC: 69168-431-86	1 in 1 CARTON	09/21/2021
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 69168-431-03	250 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M011	09/21/2021

Labeler - Allegiant Health (079501930)