Calmco Adult Sleep Aid Gummy Bite

Calmco Adult Sleep Aid Gummy Bite
SPL v2
SPL
SPL Set ID 0c534cbd-40e6-8af0-e063-6394a90a5605
Route
ORAL
Published
Effective Date 2023-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carrageenan Starch, Corn Maltitol Glyceryl Mono And Dipalmitostearate Neotame Sodium Chloride Povidone K30 Sucralose Polyethylene Glycol 400 Trisodium Citrate Dihydrate Propylene Glycol Sucrose Corn Syrup Hydroxypropyl Betadex Acacia Water Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: red Size: 15 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-12
Description

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

Medication Information

Description

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

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 55105-1
Active ingredient Purpose
Diphenhydramine HCl 25 mg .................. Nighttime sleep aid

Directions
  • take only 1 dose per day (24 hours)
  • chew each piece thoroughly before swallowing
Age (Yrs) Dose (per piece)

adults and children 12 years and over

 1 to 2 pieces (25 mg to 50 mg)
children under 12 years do not use

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
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 Or Comments?

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

Principal Display Panel

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.

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

Structured Label Content

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 55105-1 (55105-1)
Active ingredient Purpose
Diphenhydramine HCl 25 mg .................. Nighttime sleep aid

Directions
  • take only 1 dose per day (24 hours)
  • chew each piece thoroughly before swallowing
Age (Yrs) Dose (per piece)

adults and children 12 years and over

 1 to 2 pieces (25 mg to 50 mg)
children under 12 years do not use

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
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 Or Comments? (Questions or Comments?)

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

Principal Display Panel

When Using This Product (When using this product)

avoid alcoholic drinks

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:46.906455 · Updated: 2026-03-14T23:05:45.354656