CVS PHARMACY DYE FREE CHILDRENS ALLERGY CHEWS- diphenhydramine hcl tablet, chewable

CVS PHARMACY by

Drug Labeling and Warnings

CVS PHARMACY by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

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

Warnings

Do not use

• ▪ to make a child sleepy
• ▪ with any other product containing diphenhydramine, even one used on skin

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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

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

Questions or comments?

1-866-467-2748

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

INGREDIENTS AND APPEARANCE

CVS PHARMACY  DYE FREE CHILDRENS ALLERGY CHEWS
diphenhydramine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-153
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	BUBBLE GUM	Imprint Code	RP012
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-153-18	3 in 1 CARTON	03/03/2025
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/03/2025

Labeler - CVS PHARMACY, INC. (062312574)