Cvs Health Childrens Allergy Relief

Cvs Health Childrens Allergy Relief
SPL v2
SPL
SPL Set ID dbd8c221-8409-4851-a6b4-c9f5e8e346e7
Route
ORAL
Published
Effective Date 2016-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium Glycerin Potassium Citrate Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-09-07
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses
  • •
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • •
      runny nose
    • •
      sneezing
    • •
      itchy, watery eyes
    • •
      itching of the nose or throat
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50567-7

When using this product

  • •
    marked drowsiness may occur
  • •
    sedatives and tranquilizers may increase drowsiness
  • •
    excitability may occur, especially in children
Section 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if the child has

  • •
    a breathing problem such as chronic bronchitis
  • •
    glaucoma
Section 50570-1

Do not use

  • •
    to make a child sleepy
  • •
    with any other product containing diphenhydramine, even one used on skin
Directions
  • •
    find right dose on chart below
  • •
    break tab on blister
  • •
    pour liquid directly into mouth or into teaspoon
  • •
    be careful of blister edges to prevent cuts on skin
  • •
    take every 4 to 6 hours
  • •
    do not take more than 6 doses in 24 hours

Age (yr)

Dose (tsp)

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 single-dose blisters(12.5mg to 25mg)
Other Information
  • •
    each blister contains: sodium 11 mg
  • •
    store at (59-77°F)
  • •
    do not use if individual single-dose blisters are torn or broken
  • •
    see bottom panel for lot number and expiration date
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Principal Display Panel

CVS Health ™

Compare to the active ingredient in Children's

Benadryl® *

Dye-Free Liquid

Children’s Allergy Relief

Liquid Medication

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg

Antihistamine

alcohol and sugar free

Relief of:

  •  
    Sneezing;
  •  
    runny nose;
  •  
    itchy, watery eyes;
  •  
    itchy throat

Cherry Flavored

Sugar & Alcohol free

Actual Product size on Side Panel

Single Dose

10 SINGLE DOSE VIALS

This is not a child-resistant package. Keep out of reach of children

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Benadryl® Dye –Free Allergy.

TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL SINGLE-DOSE BLISTER UNIT IS BROKEN OR OPEN

Distributed by: CVS Pharmacy, Inc.

One CVS Drive,Woonsocket, RI 02895

© 2015CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A.

V-12431

CVS Quality

Money Back Guarantee

SNAP BACK AT PERFORATION LINE

POUR INTO MOUTH OR SPOON

  •  
    Use scissors to cut blister if difficult to open.
Active Ingredient (in Each 5 Ml Blister)

Diphenhydramine HCl USP 12.5 mg

Structured Label Content

Uses
  • •
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • •
      runny nose
    • •
      sneezing
    • •
      itchy, watery eyes
    • •
      itching of the nose or throat
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50567-7 (50567-7)

When using this product

  • •
    marked drowsiness may occur
  • •
    sedatives and tranquilizers may increase drowsiness
  • •
    excitability may occur, especially in children
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • •
    a breathing problem such as chronic bronchitis
  • •
    glaucoma
Section 50570-1 (50570-1)

Do not use

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

Antihistamine

Directions
  • •
    find right dose on chart below
  • •
    break tab on blister
  • •
    pour liquid directly into mouth or into teaspoon
  • •
    be careful of blister edges to prevent cuts on skin
  • •
    take every 4 to 6 hours
  • •
    do not take more than 6 doses in 24 hours

Age (yr)

Dose (tsp)

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 single-dose blisters(12.5mg to 25mg)
Other Information (Other information)
  • •
    each blister contains: sodium 11 mg
  • •
    store at (59-77°F)
  • •
    do not use if individual single-dose blisters are torn or broken
  • •
    see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CVS Health ™

Compare to the active ingredient in Children's

Benadryl® *

Dye-Free Liquid

Children’s Allergy Relief

Liquid Medication

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg

Antihistamine

alcohol and sugar free

Relief of:

  •  
    Sneezing;
  •  
    runny nose;
  •  
    itchy, watery eyes;
  •  
    itchy throat

Cherry Flavored

Sugar & Alcohol free

Actual Product size on Side Panel

Single Dose

10 SINGLE DOSE VIALS

This is not a child-resistant package. Keep out of reach of children

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Benadryl® Dye –Free Allergy.

TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL SINGLE-DOSE BLISTER UNIT IS BROKEN OR OPEN

Distributed by: CVS Pharmacy, Inc.

One CVS Drive,Woonsocket, RI 02895

© 2015CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A.

V-12431

CVS Quality

Money Back Guarantee

SNAP BACK AT PERFORATION LINE

POUR INTO MOUTH OR SPOON

  •  
    Use scissors to cut blister if difficult to open.
Active Ingredient (in Each 5 Ml Blister) (Active ingredient (in each 5 mL blister))

Diphenhydramine HCl USP 12.5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:28.668047 · Updated: 2026-03-14T22:54:57.914892