OTC Medication Information: Betr Sleep Aid

BETR SLEEP AID- diphenhydramine hydrochloride tablet, film coated
Live Betr LLC

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 caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

in 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
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 drinks
drowsiness may 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 serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

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

do not use

Other information

each caplet contains: calcium 15 mg
store at 20-25° C (68-77° F). Avoid high humidity. Protect from light.
do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

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Betr

sleep aid

DIPHENHYDRAMINE HCl CAPLETS 25 mg

Actual Size

Nighttime Sleep Aid

– Relief Of Occasional Sleeplessness

48 CAPLETS

sleep aid image
(click image for full-size original)
BETR SLEEP AID
diphenhydramine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80267-431
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSPOVIDONE (15 MPA.S AT 5%)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code L431
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80267-431-67 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 2 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (80267-431-67)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 01/25/2021
Labeler — Live Betr LLC (117423281)

Revised: 07/2022 Live Betr LLC

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.

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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