cvs dye-free children’s allergy chews

cvs dye-free children’s allergy chews
SPL v2
SPL
SPL Set ID e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7
Route
oral
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (12.5 mg)
Inactive Ingredients
crospovidone (120 .mu.m) dextrose, unspecified form magnesium stearate maltodextrin potassium citrate silicon dioxide sodium polystyrene sulfonate starch, corn sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP012 Shape: round Color: white Size: 16 mm Score: 2
Marketing Status
otc monograph drug active Since 2025-03-03

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg


Medication Information

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 the 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 (Year)

Dose (chewable tablets)

children under 2 years

do not use 

children 2 to under 5 years

do not use unless directed by a doctor 

children 6 to under 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 at room temperature.
  • Avoid high humidity. Protect from light.
Inactive Ingredients

Crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose

Description

Diphenhydramine HCl 12.5 mg

Principal Display Panel

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

NDC 51316-153-18

Dye-Free

Children's Allergy Chews

Diphenhydramine HCl, / Antihistamine

For relief of:

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

4-6 Hours/Dose

Bubblegum Flavor

Naturally and Artificially Flavored

18 Chewable Tablets

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 Kenvue INC., owner of the registered trademark Children's Benadryl® Dye Free Allergy Chewable Tablets.

Distributed by:



IMPORTANT: Keep this carton for future reference on full labeling

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 A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 the 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 (Year)

Dose (chewable tablets)

children under 2 years

do not use 

children 2 to under 5 years

do not use unless directed by a doctor 

children 6 to under 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 (Other information)
  • store at room temperature.
  • Avoid high humidity. Protect from light.
Inactive Ingredients (Inactive ingredients)

Crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose

Principal Display Panel

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

NDC 51316-153-18

Dye-Free

Children's Allergy Chews

Diphenhydramine HCl, / Antihistamine

For relief of:

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

4-6 Hours/Dose

Bubblegum Flavor

Naturally and Artificially Flavored

18 Chewable Tablets

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 Kenvue INC., owner of the registered trademark Children's Benadryl® Dye Free Allergy Chewable Tablets.

Distributed by:



IMPORTANT: Keep this carton for future reference on full labeling

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 A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

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