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

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg


Medication Information

Active Ingredient

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
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

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

Description

Diphenhydramine HCl 12.5 mg

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

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

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

Active Ingredient (Active ingredient (in each tablet))

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
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

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

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

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

All Sections (JSON)