CalmCo Sleep Aid Gummies (AFL)

Manufacturer: CalmCo LLC
Effective date: 2026-06-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: monthly-update
Hydrated at: 2026-07-17 21:36:48

Label at a glance#

ProductCalmCo Sleep Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

■ do not take more than directed ■ chew thoroughly before swallowing Age Dose (chew) adults and children 12 years and over take 2 chewables at bedtime if needed children under 12 years do not use

Storage and handling

■ store between 68-77°F (20-25°C) ■ avoid high humidity and protect from light ■ do not use if foil seal under cap is torn, broken or missing ■ see bottom of bottle for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact+1-941-203-4509

Websitewww.calmco.com

www.calmco.com

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

__________

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient	Purpose
Diphenhydramine HCl 25 mg ..................	Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

■ for relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

________

Do not use

OTC - DO NOT USE SECTION

■ with any other product containing diphenhydramine, even one used on skin

■ in children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ have a breathing problem such as emphysema or chronic bronchitis

■ have glaucoma

■ have trouble urinating due to an enlarged prostate gland

■ are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ avoid alcohol beverages

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 serious underlying medical illness.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than directed

■ chew thoroughly before swallowing

Age	Dose (chew)
adults and children 12 years and over	take 2 chewables at bedtime if needed
children under 12 years	do not use

Other Information

STORAGE AND HANDLING SECTION

■ store between 68-77°F (20-25°C)

■ avoid high humidity and protect from light

■ do not use if foil seal under cap is torn, broken or missing

■ see bottom of bottle for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

beta-cyclodextrin, carrageenan, corn syrup, flavors, purified water, sucrose, sucralose

Questions or Comments?

OTC - QUESTIONS SECTION

+1-941-203-4509 (M-F) 9 AM - 5 PM EST or www.calmco.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SA Gummy 20ct FTSA Gummy 30ct FTSA Gummy 20ct Berry

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

CalmCo Sleep Aid
Diphenhydramine HCl
CARRAGEENAN
SUCRALOSE
SUCROSE
CORN SYRUP
BETADEX
WATER
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73282-2528	73282-2528-1
73282-2527	73282-2527-1, 73282-2527-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARRAGEENAN	5C69YCD2YJ	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SUCROSE	C151H8M554	IACT
CORN SYRUP	9G5L16BK6N	IACT
BETADEX	JV039JZZ3A	IACT
WATER	059QF0KO0R	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
CARRAGEENAN	5C69YCD2YJ	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SUCROSE	C151H8M554	IACT
CORN SYRUP	9G5L16BK6N	IACT
BETADEX	JV039JZZ3A	IACT
WATER	059QF0KO0R	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CalmCo Sleep Aid	DIPHENHYDRAMINE HCL	CalmCo LLC	552d0e50-a58c-8e47-e063-6394a90a8f7b	2026-06-26	Warnings	Exact identifier ndc (package): 73282-2528-1 ndc (package): 73282-2527-2 ndc (package): 73282-2527-1 ndc (product): 73282-2528 ndc (product): 73282-2527 ndc11 (package): 73282252702 ndc11 (package): 73282252801 ndc11 (package): 73282252701 spl id: 552d0e50-a58d-8e47-e063-6394a90a8f7b spl set id: 552d0e50-a58c-8e47-e063-6394a90a8f7b

Reported adverse events (FAERS/openFDA)#

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