SOUND BODY SLEEP AID- diphenhydramine hcl 25 mg tablet, coated

Sound Body Sleep Aid by

Drug Labeling and Warnings

Sound Body 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 (in each caplet)

Diphenhydramine HCl 25mg

Purpose

Nighttime Sleep aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use

• in children under 12 years of age
• with any other product containing diphenydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages
• drowsiness will occur
• do not drive a motor vehicle or operate 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,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions

adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years of age: do not use

Other information

• store at room temperature store between 20-25°C (68-77°F)
• do not use if blister unit is torn or open 

Inactive ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Principal Display Panel

SOUNDBODY™

Compare to the Active Ingredients in Simply Sleep®*

For Nighttime Use
Sleep Aid
Diphenhydramine HCl 25 mg

• Does not contain Pain Reliever
  

24 Caplets

(pill image) Actual Size

Distributed by: Allegiant Health
Deer Park, NY 11729

V#5003620 ITEM#FP064

LB1307
R0617

Questions or Comments?
1-888-952-0050

Sleep Aid 24ct.

INGREDIENTS AND APPEARANCE

SOUND BODY SLEEP AID 
diphenhydramine hcl 25 mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-910
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	AZ;263
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-910-93	2 in 1 CARTON	03/03/2015
1		12 in 1 BLISTER PACK; 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	03/03/2015

Labeler - Allegiant Health (079501930)