Childrens Allergy Relief: Package Insert and Label Information

CHILDRENS ALLERGY RELIEF- 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • 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 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 a 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

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-800-426-9391

Principal Display Panel

♥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

Actual Size

Grape 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 REV1218D58544

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2021 CVS/pharmacy
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V-18615

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CVS Health 44-585
(click image for full-size original)

CVS Health 44-585

CHILDRENS ALLERGY RELIEF diphenhydramine hcl tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-585
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
D&C RED NO. 27 ALUMINUM LAKE
D&C RED NO. 30
DEXTROSE MONOHYDRATE
ETHYLCELLULOSE, UNSPECIFIED
FD&C BLUE NO. 1 ALUMINUM LAKE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
STEARIC ACID
SUCRALOSE
SUCROSE
Product Characteristics
Color purple Score no score
Shape ROUND Size 12mm
Flavor GRAPE Imprint Code 44;585
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-585-07 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (59779-585-07)
2 NDC:59779-585-44 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (59779-585-44)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/20/2009
Labeler — CVS Pharmacy (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (59779-585)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (59779-585)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (59779-585)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (59779-585)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (59779-585)

Revised: 06/2022 CVS Pharmacy

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