Drx Choice Children’s Allergy Chews

Drx Choice Children’s Allergy Chews
SPL v4
SPL
SPL Set ID dd2be906-bd0a-437c-9693-54b9391a5da3
Route
ORAL
Published
Effective Date 2022-07-19
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 2022-07-04

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

Age (Yr)

Dose (chewable tablets)

children under 2 years of age

do not use 

children 2 to under 5 years of age

do not use unless directed by a doctor 

children 6 to under 12 years of age 

1 to 2 tablets 

adults and children 12 years of age and over

2 to 4 tablets

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

Principal Display Panel

NDC 68163-012-48

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

DRx Choice

children's allergy chews

diphenhydramine HCl, 12.5 mg/ antihistamine

For Relief of:

  • Sneezing
  • Runny nose
  • Itchy throat or Nose
  • Itchy, watery eyes

48 Chewable Tablets

Grape Flavor

4-6 HOURS/DOSE

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick,

NJ 08816

IMPORTANT:Keep this carton for future reference on full labelling

Questions Or Comments ?

  1-866-467-2748

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

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 12.5 mg

Ask Your Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
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
  • chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
  • Find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

Age (Yr)

Dose (chewable tablets)

children under 2 years of age

do not use 

children 2 to under 5 years of age

do not use unless directed by a doctor 

children 6 to under 12 years of age 

1 to 2 tablets 

adults and children 12 years of age and over

2 to 4 tablets

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 below 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

Principal Display Panel

NDC 68163-012-48

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

DRx Choice

children's allergy chews

diphenhydramine HCl, 12.5 mg/ antihistamine

For Relief of:

  • Sneezing
  • Runny nose
  • Itchy throat or Nose
  • Itchy, watery eyes

48 Chewable Tablets

Grape Flavor

4-6 HOURS/DOSE

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick,

NJ 08816

IMPORTANT:Keep this carton for future reference on full labelling

Questions Or Comments ? (Questions or comments ?)

  1-866-467-2748

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 12.5 mg

Ask Your Doctor Before Use If You Have (Ask your doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
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

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