ADULT ALLERGY RELIEF- calmco allergy relief bar, chewable

Adult Allergy Relief by

Drug Labeling and Warnings

Adult Allergy Relief by is a Otc medication manufactured, distributed, or labeled by CalmCo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each piece)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
■ runny nose
■ itchy, watery eyes
■ sneezing
■ itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
■ runny nose
■ sneezing

WARNINGS

Do not use

To make child sleepy
with any other product containing diphenhydramine, even one used on skin

When Using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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

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

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours
chew each piece thoroughly before swallowing

Dosage Chart

• Age (yr): Dose (piece)
• Adults and children 12 years and older: 1 to 2 pieces (25 to 50 mg)
• Children under 12 years: Do not use

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

Inactive ingredients: FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum atabic,
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 calmco.com

Package- outer label

INGREDIENTS AND APPEARANCE

ADULT ALLERGY RELIEF 
calmco allergy relief bar, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-2520
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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)
NEOTAME (UNII: VJ597D52EX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STARCH, CORN (UNII: O8232NY3SJ)
MALTITOL (UNII: D65DG142WK)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
ACACIA (UNII: 5C5403N26O)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
CARRAGEENAN (UNII: 5C69YCD2YJ)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	RECTANGLE	Size	15mm
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-2520-1	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/20/2023

Labeler - CalmCo (079308308)

Registrant - CalmCo (079308308)