Calmco Adult Allergy Relief (cc)

Calmco Adult Allergy Relief (cc)
SPL v2
SPL
SPL Set ID 471b1a43-1708-8be7-e063-6394a90a9bb7
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

.


Medication Information

Description

.

Uses

Temporarily relieves

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • other upper respiratory allergies
Section 55105-1
Active ingredient (in each 10 mL vial) Purpose
Diphenhydramine HCl 25 mg............... Antihistamine

Warnings

.

Directions
  • do not exceed 12 vials in a 24-hour period
  • follow the “Easy to Use” instructions on pouch

Age Dose
Adults and children 12 years of age and older take 1 - 2 vials every 4-6 hours
children under 12 years of age do not use

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

.

Other Information
  • each 10 mL vial contains: sodium 4mg
  • 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
  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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
  • have 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

Temporarily relieves

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • other upper respiratory allergies
Section 55105-1 (55105-1)
Active ingredient (in each 10 mL vial) Purpose
Diphenhydramine HCl 25 mg............... Antihistamine

Warnings

.

Directions
  • do not exceed 12 vials in a 24-hour period
  • follow the “Easy to Use” instructions on pouch

Age Dose
Adults and children 12 years of age and older take 1 - 2 vials every 4-6 hours
children under 12 years of age do not use

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

.

Other Information (Other information)
  • each 10 mL vial contains: sodium 4mg
  • 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
  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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
  • have 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

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