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

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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SoundBody Sleep Aid

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.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69168-910-93	2 in 1 CARTON	03/03/2015	12/31/2022
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	03/03/2015	12/31/2022

Labeler - Allegiant Health (079501930)

Revised: 11/2017

Document Id: 78c523df-c041-468a-bffc-25fa2a9fb5c1

Set id: 4ddcf701-ce91-4d44-bee7-66e382691ccc

Version: 5

Effective Time: 20171115

Allegiant Health