Rite Aid 44-018

Rite Aid 44-018
SPL v4
SPL
SPL Set ID 74ff4f0d-7952-4b74-b1b2-5a2beab91f7c
Route
ORAL
Published
Effective Date 2025-05-10
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 Active Since 2023-05-01

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
    • sneezing 
    • itchy, watery eyes
    • 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?

1-800-426-9391

Principal Display Panel

FREE

FROM

SUGAR FREE

ALCOHOL FREE

Compare to the

active ingredient in

Children’s Benadryl®

Dye-Free Allergy*

NDC 11822-0918-1

AGES 6-11

CHILDREN’S

DYE-FREE

ALLERGY
RELIEF

DIPHENHYDRAMINE

HCl 12.5 mg / 5 mL

Oral Solution

ANTIHISTAMINE

for relief of:

sneezing,

runny nose,

itchy throat or nose,

itchy, watery eyes

CLEAR BUBBLE

GUM FLAVOR

DOSAGE CUP INCLUDED

4 FL OZ (118 mL)

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Children’s Benadryl® Dye-Free Allergy.

50844              ORG012301836

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

OUR PROMISE

Dye Free

DOSAGE CUP INCLUDED

DISTRIBUTED BY:

RITE AID

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION

GUARANTEE

If you’re not satisfied, we’ll

happily refund your money.

Rite Aid 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
  • glaucoma
  • a breathing problem such as chronic bronchitis
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
    • sneezing 
    • itchy, watery eyes
    • 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?)

1-800-426-9391

Principal Display Panel

FREE

FROM

SUGAR FREE

ALCOHOL FREE

Compare to the

active ingredient in

Children’s Benadryl®

Dye-Free Allergy*

NDC 11822-0918-1

AGES 6-11

CHILDREN’S

DYE-FREE

ALLERGY
RELIEF

DIPHENHYDRAMINE

HCl 12.5 mg / 5 mL

Oral Solution

ANTIHISTAMINE

for relief of:

sneezing,

runny nose,

itchy throat or nose,

itchy, watery eyes

CLEAR BUBBLE

GUM FLAVOR

DOSAGE CUP INCLUDED

4 FL OZ (118 mL)

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Children’s Benadryl® Dye-Free Allergy.

50844              ORG012301836

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

OUR PROMISE

Dye Free

DOSAGE CUP INCLUDED

DISTRIBUTED BY:

RITE AID

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION

GUARANTEE

If you’re not satisfied, we’ll

happily refund your money.

Rite Aid 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)
  • glaucoma
  • a breathing problem such as chronic bronchitis
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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