OTC Medication Information: Childrens Allergy Relief Dye Free

CHILDRENS ALLERGY RELIEF DYE FREE- diphenhydramine hydrochloride tablet, chewable
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • avoid alcoholic beverages
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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 (1-800-222-1222) right away.

Directions

  • find right dose on chart below
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take every 4 to 6 hours, or as directed by 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 chewable tablets (25 mg to 50 mg)

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, maltodextrin, mannitol, stearic acid, sucralose, triacetin

Questions or comments?

1-800-426-9391

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♥CVS Health

Compare to the active ingredient in Children’s Benadryl® Chewables*

Chewable Tablets

Children’s
Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE, 12.5 mg
CHEWABLE TABLETS

Antihistamine

Relief of:
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat

DYE
FREE

Actual Size
Bubble Gum Flavored
Child-Resistant Packaging

18 CHEWABLE TABLETS

Chew or crush tablets completely before swallowing.

TAMPER EVIDENT: DO NOT USE IF PACKAGE 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 Corporation, owner of the registered trademark Children’s Benadryl® Chewables.
50844 REV1218B66944

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-18615

CVS® QualityMoney Back Guarantee

CVS 44-669
(click image for full-size original)

CVS 44-669

CHILDRENS ALLERGY RELIEF DYE FREE diphenhydramine hcl tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-869
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
ETHYLCELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MALTODEXTRIN
MANNITOL
STEARIC ACID
SUCRALOSE
TRIACETIN
DEXTROSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor BUBBLE GUM Imprint Code 44;669
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-869-44 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (59779-869-44)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/20/2015
Labeler — CVS Pharmacy (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (59779-869)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (59779-869)

Revised: 04/2021 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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