CALMCO SLEEP AID GUMMY BITE- diphenhydramine hcl bar, chewable

CalmCo Sleep Aid Gummy Bite by

Drug Labeling and Warnings

CalmCo Sleep Aid Gummy Bite by is a Otc medication manufactured, distributed, or labeled by CalmCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each piece)

Diphenhydrarnine HCI 25 mg

Purpose

Nighttime Sleep Aid

Uses

• For the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

WARNINGS

Do not use

• for 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

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

ask a health professional before use.

Keep out of reach of children

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

Directions

• Take only 1 dose per day (24 hours)
• Chew each piece thoroughly before swallowing

Dosage Chart

• Age (Years): Dose (Piece)
• Adults and children 12 years and over: 1 to 2 pieces (25 mg to 50 mg)
• children under 12 years: Do not use

Other Information

• Each piece: contains sodium 9 mg. low sodium
• Store in a cool dry place between 20-25°C (68-77°F).
• Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients

FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions of Comments?

Call 941-203-4590 or visit www.calmco.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALMCO SLEEP AID GUMMY BITE 
diphenhydramine hcl bar, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-2518
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
CARRAGEENAN (UNII: 5C69YCD2YJ)
STARCH, CORN (UNII: O8232NY3SJ)
MALTITOL (UNII: D65DG142WK)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
NEOTAME (UNII: VJ597D52EX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POVIDONE K30 (UNII: U725QWY32X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
ACACIA (UNII: 5C5403N26O)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	RECTANGLE	Size	15mm
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-2518-1	25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	12/12/2023

Labeler - CalmCo LLC (079308308)

Registrant - CalmCo LLC (079308308)