CALMCO SLEEP AID GUMMY BITE- diphenhydramine hcl bar, chewable 
CalmCo LLC

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CalmCo Adult Sleep Aid Gummy Bite

Active Ingredient (in each piece)

Diphenhydrarnine HCI 25 mg

Purpose

Nighttime Sleep Aid

Uses

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

Dosage Chart

Age (Years)Dose (Piece)
Adults and children 12 years and over1 to 2 pieces (25 mg to 50 mg)
children under 12 yearsDo not use

Other Information

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

Sleep Aid PDPsleep aid peel back

CALMCO SLEEP AID GUMMY BITE 
diphenhydramine hcl bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-2518
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScorescore with uneven pieces
ShapeRECTANGLESize15mm
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-2518-125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01012/12/2023
Labeler - CalmCo LLC (079308308)
Registrant - CalmCo LLC (079308308)

Revised: 12/2023
Document Id: 0c534cbd-40e7-8af0-e063-6394a90a5605
Set id: 0c534cbd-40e6-8af0-e063-6394a90a5605
Version: 1
Effective Time: 20231212
 
CalmCo LLC