CHILDRENS CHEWABLE ALLERGY RELIEF- diphenhydramine hydrochloride tablet, chewable

Childrens Chewable Allergy Relief by

Drug Labeling and Warnings

Childrens Chewable Allergy Relief by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

-runny nose
-sneezing
-itchy, watery eyes
-itching of the nose or throat

Warnings

Do not use

• to make a child sleepy
• 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
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

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

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 right away (1-800-222-1222).

Directions

• find right dose on chart below
• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours

• Age (years): Dose (chewable tablets)
• children under 2 years: do not use
• children 2 to 5 years: do not use unless directed by a doctor
• children 6 to 11 years: 1 to 2 chewable tablets (12.5 mg to 25 mg)
• adults and children 12 years and over:

  2 to 4 chewable tablets (25 mg to 50 mg)

Other information

• store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.

Inactive ingredients

acacia, crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7, dextrose monohydrate, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sucralose, sucrose, tartaric acid

Questions or comments?

Call 1-800-632-6900

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS CHEWABLE ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-669
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CROSPOVIDONE (UNII: 2S7830E561)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 30 ALUMINUM LAKE (UNII: GE75M6YV5W)
ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TARTARIC ACID (UNII: W4888I119H)

Product Characteristics
Color	purple (Mottled purple color)	Score	no score
Shape	ROUND	Size	13mm
Flavor	GRAPE	Imprint Code	122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-669-02	2 in 1 CARTON	04/30/2025
1		10 in 1 BLISTER PACK; 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	04/30/2025

Labeler - KROGER COMPANY (006999528)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(41226-669)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(41226-669)