Target 44-018-liquid-delisted

Target 44-018-liquid-delisted
SPL v12
SPL
SPL Set ID 6cc45cb4-0e48-49ad-829f-b78a4f622ab4
Route
ORAL
Published
Effective Date 2025-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-05-20 Until 2026-09-30

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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
Directions
  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 Age (yr) Dose (mL)
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  5 mL to 10 mL

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each 5 mL contains: sodium 4 mg

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments?

Call 1-800-910-6874

Principal Display Panel

NDC 11673-918-36

Compare to active

ingredient in

Children's Benadryl®

Dye-Free Allergy
*

dye-free

children's

allergy

relief

diphenhydramine HCl, 12.5 mg

per 5 mL oral solution/antihistamine

alcohol and sugar free

for relief of:

• runny nose

• sneezing

• itchy, watery eyes

• itchy throat or nose

up & up

BUBBLEGUM

FLAVOR

AGES

6-11

YEARS

4 FL OZ (118 mL)

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Dye-Free Allergy.

50844 REV0123A01836

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100% satisfaction guaranteed

or your money back.

Each year we give 5% of our profit to

communities. See all the good we do 

together at Target.com/Community.

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2023 Target Brands, Inc.

Target 44-018
When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If the Child Is

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
  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 Age (yr) Dose (mL)
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  5 mL to 10 mL

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • each 5 mL contains: sodium 4 mg

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

Principal Display Panel

NDC 11673-918-36

Compare to active

ingredient in

Children's Benadryl®

Dye-Free Allergy
*

dye-free

children's

allergy

relief

diphenhydramine HCl, 12.5 mg

per 5 mL oral solution/antihistamine

alcohol and sugar free

for relief of:

• runny nose

• sneezing

• itchy, watery eyes

• itchy throat or nose

up & up

BUBBLEGUM

FLAVOR

AGES

6-11

YEARS

4 FL OZ (118 mL)

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Dye-Free Allergy.

50844 REV0123A01836

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100% satisfaction guaranteed

or your money back.

Each year we give 5% of our profit to

communities. See all the good we do 

together at Target.com/Community.

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2023 Target Brands, Inc.

Target 44-018
When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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