Sound Body Sleep Aid

Manufacturer
Allegiant Health
Effective date
2017-11-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:55:51

Label at a glance#

ProductSound Body Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

for relief of occasional sleeplessness

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Nighttime Sleep aid

Uses

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.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.
Sleep Aid 24ct.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-910-932020-12-03C16284748780-19d75b9d0-b656-f424-e053-dadaa90a57ceSoundBody Sleep Aid
69168-910-932020-01-31C16284748780-19d75b9d0-b656-f424-e053-dadaa90a57ceSoundBody Sleep Aid

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-91069168-910-93

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
78c523df-c041-468a-bffc-25fa2a9fb5c14ddcf701-ce91-4d44-bee7-66e382691ccc2017-11-15WarningsExact identifier
spl id: 78c523df-c041-468a-bffc-25fa2a9fb5c1
spl set id: 4ddcf701-ce91-4d44-bee7-66e382691ccc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.