Calmco Adult Sleep Aid

Calmco Adult Sleep Aid
SPL v1
SPL
SPL Set ID 471d4c70-813a-19de-e063-6394a90aeb25
Route
ORAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Sucralose Anhydrous Citric Acid Sorbitol Sodium Benzoate Glycerin Water Propylene Glycol Xylitol Carboxymethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01
Description

.

Purpose

.

Medication Information

Purpose

.

Description

.

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 55105-1
Active ingredient (in each 10 mL vial) Purpose
Diphenhydramine HCl 25 mg............... Nighttime sleep-aid

Warnings

.

Directions
  • do not take more than directed
  • follow the “Easy to Use” instructions on pouch

Age Dose
Adults and children 12 years and older take 2 vials at bedtime, if needed
children under 12 years do not use

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • on children under 12 years of age
Drug Facts

.

Other Information
  • each 10 mL vial contains: sodium 4 mg
  • store between 68-77°F (20-25°C)
  • do not use if pouch has been torn open or vial is punctured or open
Inactive Ingredients

Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, water, xylitol

Questions Or Comments?

+1 941-203-4590 (M-F) 9am-5pm EST or visit www.calmco.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Made in Dominican Republic

Principal Display Panel

When Using This Product

avoid consuming alcohol beverages

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.
Active Ingredient and Purpose

.

If Pregnant Or Breastfeeding,

ask a healthcare professional before use

Ask A Doctor Before Use If You
  • have a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • have trouble urinating due to an enlarged prostate gland
  • are taking sedatives or tranquilizers
Keep Out of Reach of Children.

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

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 (in each 10 mL vial) Purpose
Diphenhydramine HCl 25 mg............... Nighttime sleep-aid

Warnings

.

Directions
  • do not take more than directed
  • follow the “Easy to Use” instructions on pouch

Age Dose
Adults and children 12 years and older take 2 vials at bedtime, if needed
children under 12 years do not use

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • on children under 12 years of age
Drug Facts

.

Other Information (Other information)
  • each 10 mL vial contains: sodium 4 mg
  • store between 68-77°F (20-25°C)
  • do not use if pouch has been torn open or vial is punctured or open
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, water, xylitol

Questions Or Comments? (Questions or comments?)

+1 941-203-4590 (M-F) 9am-5pm EST or visit www.calmco.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Made in Dominican Republic

Principal Display Panel

When Using This Product (When using this product)

avoid consuming alcohol beverages

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.
Active Ingredient and Purpose

.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a healthcare professional before use

Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • have a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • have trouble urinating due to an enlarged prostate gland
  • are taking sedatives or tranquilizers
Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:00.469604 · Updated: 2026-03-14T23:12:06.957806