Kroger Diphenhydramine Hydrochloride 12.5 Mg Chewable Tablets - Childrens Grape Flavor

Kroger Diphenhydramine Hydrochloride 12.5 Mg Chewable Tablets - Childrens Grape Flavor
SPL v3
SPL
SPL Set ID 2cac72be-4830-ad49-e063-6394a90a7832
Route
ORAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Acacia D&c Red No. 7 Crospovidone Microcrystalline Cellulose Sucrose Dextrose Monohydrate Fd&c Blue No. 1 Aluminum Lake Sucralose D&c Red No. 30 Aluminum Lake Ethylcellulose Hydroxypropylcellulose Magnesium Stearate Tartaric Acid

Identifiers & Packaging

Pill Appearance
Imprint: 122 Shape: round Color: purple Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-30
Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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

Section 50565-1

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).

Section 50568-5

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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)

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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

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
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
Active Ingredient (in Each Chewable Tablet)

Diphenhydramine HCl 12.5 mg

Structured Label Content

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

Section 50565-1 (50565-1)

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).

Section 50568-5 (50568-5)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

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)

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Inactive Ingredients (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? (Questions or comments?)

Call 1-800-632-6900

When Using This Product (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
Ask A Doctor Before Use If You Have (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
Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Diphenhydramine HCl 12.5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:46.344914 · Updated: 2026-03-14T23:09:44.239716