Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 02f483cd-b9b8-4c93-9b5a-a4ab84965d4e
Route
ORAL
Published
Effective Date 2024-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Poloxamer 407 Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucrose D&c Red No. 33 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-10

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:
    • sneezing

    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on chart below 
age (yrs) dose (mL)
 children 6 to 11 years  5 mL to 10 mL
 children 2 to 5 years  do not use unless directed by a doctor
 children under 2 years  do not use


Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Product Label
HARRIS TEETER Children's Allergy Liquid Cherry Flavor
Other Information
  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Protect from light. Store in outer carton until contents are used
Inactive Ingredients

anhydrous citric acid, D&C red #33, RD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy**

Children's

Allergy Liquid

12.5 mg / 5 mL

Diphenhydramine HCl Oral Solution

ANTIHISTAMINE

Relieves:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching of the Nose or Throat

For ages 6 to 11 years

FL OZ (mL)

CHERRY FLAVOR

Dosage Cup Included

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Keep Out of the Reach of Children.

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

Ask A Doctor Before Use If the Child Has
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet
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:
    • sneezing

    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
Purpose

Antihistamine

Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on chart below 
age (yrs) dose (mL)
 children 6 to 11 years  5 mL to 10 mL
 children 2 to 5 years  do not use unless directed by a doctor
 children under 2 years  do not use


Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Product Label
HARRIS TEETER Children's Allergy Liquid Cherry Flavor
Other Information (Other information)
  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Protect from light. Store in outer carton until contents are used
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red #33, RD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments? (Questions or comments?)

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy**

Children's

Allergy Liquid

12.5 mg / 5 mL

Diphenhydramine HCl Oral Solution

ANTIHISTAMINE

Relieves:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching of the Nose or Throat

For ages 6 to 11 years

FL OZ (mL)

CHERRY FLAVOR

Dosage Cup Included

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

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
  • a sodium-restricted diet
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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