wal-mart children’s allergy relief drug facts

wal-mart children’s allergy relief drug facts
SPL v6
SPL
SPL Set ID b05acd16-21cb-4ee0-afa0-8f7d59166435
Route
oral
Published
Effective Date 2024-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (12.5 mg)
Inactive Ingredients
anhydrous citric acid d&c red no. 33 fd&c red no. 40 glycerin high fructose corn syrup poloxamer 407 water sodium benzoate sodium chloride sodium citrate, unspecified form sorbitol solution

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 1990-08-15 Until 2024-07-31

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg


Medication Information

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

Antihistamine

Directions
  • find right dose on chart below
  • mL = milliliter
  • 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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information
  • each 5 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if printed neckband is broken or missing
Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Description

Diphenhydramine HCl 12.5 mg

Principal Display Panel

equate™

Compare to Children’s Benadryl® Allergy Liquid active ingredient

children’s ALLERGY RELIEF

Diphenhydramine HCl

Antihistamine

12.5 mg/5 mL Oral Solution

AGES 6 to 11 YEARS

Relief of:

• Runny nose

• Sneezing

• Itchy, watery eyes

• Itchy throat or nose

• Alcohol Free

• 4-6 Hours/Dose

Cherry Flavored

4 FL OZ (118 mL)

Dosage Cup Included

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments?

1-888-287-1915

When Using This Product
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness
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).

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

Antihistamine

Directions
  • find right dose on chart below
  • mL = milliliter
  • 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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information (Other information)
  • each 5 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if printed neckband is broken or missing
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Principal Display Panel

equate™

Compare to Children’s Benadryl® Allergy Liquid active ingredient

children’s ALLERGY RELIEF

Diphenhydramine HCl

Antihistamine

12.5 mg/5 mL Oral Solution

AGES 6 to 11 YEARS

Relief of:

• Runny nose

• Sneezing

• Itchy, watery eyes

• Itchy throat or nose

• Alcohol Free

• 4-6 Hours/Dose

Cherry Flavored

4 FL OZ (118 mL)

Dosage Cup Included

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness
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 (1-800-222-1222).

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
  • 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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