CALMCO ALLERGY RELIEF- diphenhydramine hcl solution

Calmco by

Drug Labeling and Warnings

Calmco by is a Otc medication manufactured, distributed, or labeled by CalmCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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Active ingredient and Purpose

• Active ingredient (in each 10 mL vial): Purpose
• Diphenhydramine HCl 25 mg...............: Antihistamine

Uses

Temporarily relieves

• runny nose
• sneezing
• itchy nose or throat
• itchy, watery eyes due to hay fever
• other upper respiratory allergies

Warnings

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Do not use

• 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
• have glaucoma
• have trouble urinating due to an enlarged prostate gland
• are taking sedatives or tranquilizers

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.

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).

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

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

INGREDIENTS AND APPEARANCE

CALMCO  ALLERGY RELIEF
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-2524
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  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-2524-2	18 in 1 POUCH	01/01/2026
1	NDC: 73282-2524-1	10 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2026

Labeler - CalmCo LLC (079308308)