Ddm Children’s Allergy Chewable Tablets Drug Facts

Ddm Children’s Allergy Chewable Tablets Drug Facts
SPL v1
SPL
SPL Set ID 51de95da-e8e8-48f0-9fa4-6191aa4a247b
Route
ORAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone (120 .mu.m) D&c Red No. 30 Dextrose, Unspecified Form Fd&c Blue No. 1 Magnesium Stearate Maltodextrin Potassium Citrate Silicon Dioxide Sodium Polystyrene Sulfonate Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP012 Shape: round Color: purple Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-19

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
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
Directions
  • find right dose on chart below
  • Chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 times in 24 hours

Age (Yr)

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 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
  • each chewable tablet contains: sodium 3 mg
  • store at room temperature. Avoid high humidity. Protect from light
Inactive Ingredients

citric acid, crospovidone, D&C Red No. 30, dextrose, FD&C Blue No. 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.

Questions Or Comments?

  1-866-467-2748

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy Chewable Tablets*

NDC 53943-033-20

DISCOUNT

Drug mart

Children’s Allergy Chewable Tablets

DIPHENHYDRAMINE HCL, / ANTIHISTAMINE

For Relief of:

  • sneezing
  • runny nose
  • itchy throat or nose
  • itchy, watery eyes

4-6 Hours/Dose

Grape Flavor

Naturally and Artificially Flavored

20 Chewable Tablets

TAMPER EVIDENT: DO NOT USE IF CARTON OR BLISTER UNIT IS BROKEN OR OPEN.

*This product is not manufactured or distributed by Kenvue INC., owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets*.



Distributed by: Discount Drug Mart

211 Commerce Drive

Medina, OH 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED. IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS NAD EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256.

IMPORTANT:Keep this carton for future reference on full labeling.

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
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 at 1-800-222-1222.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

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
Purpose

Antihistamine

Directions
  • find right dose on chart below
  • Chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 times in 24 hours

Age (Yr)

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 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)
  • each chewable tablet contains: sodium 3 mg
  • store at room temperature. Avoid high humidity. Protect from light
Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, D&C Red No. 30, dextrose, FD&C Blue No. 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.

Questions Or Comments? (Questions or comments?)

  1-866-467-2748

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy Chewable Tablets*

NDC 53943-033-20

DISCOUNT

Drug mart

Children’s Allergy Chewable Tablets

DIPHENHYDRAMINE HCL, / ANTIHISTAMINE

For Relief of:

  • sneezing
  • runny nose
  • itchy throat or nose
  • itchy, watery eyes

4-6 Hours/Dose

Grape Flavor

Naturally and Artificially Flavored

20 Chewable Tablets

TAMPER EVIDENT: DO NOT USE IF CARTON OR BLISTER UNIT IS BROKEN OR OPEN.

*This product is not manufactured or distributed by Kenvue INC., owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets*.



Distributed by: Discount Drug Mart

211 Commerce Drive

Medina, OH 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED. IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS NAD EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256.

IMPORTANT:Keep this carton for future reference on full labeling.

When Using This Product (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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)