American Sales Company Children’s Allergy Relief Drug Facts

American Sales Company Children’s Allergy Relief Drug Facts
SPL v3
SPL
SPL Set ID bb78ef2c-4f42-4e8f-b38d-f9b2965a384b
Route
ORAL
Published
Effective Date 2024-07-19
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 High Fructose Corn Syrup Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sorbitol Solution Glycerin

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-12
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
    • •
      itching of the nose or throat
    • •
      runny nose
    • •
      itchy, watery eyes
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.

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

Questions Or Comments?

1-800-719-9260

Principal Display Panel

CAREone®

Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

For Ages 6 to 11 Years

Children’s Allergy Relief

Diphenhydramine HCl 12.5 mg/5 mL Oral Solution

Antihistamine

dosage cup included

Cherry Flavored

RELIEF OF:

• Runny Nose

• Sneezing

• Itchy, Watery Eyes

• Itchy Throat or Nose

• 4-6 Hours/Dose

• Alcohol Free

• Gluten Free

4 FL OZ (118mL)

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.

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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

CAREone®

Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

For Ages 6 to 11 Years

Children’s Allergy Relief

Diphenhydramine HCl 12.5 mg/5 mL Oral Solution

Antihistamine

dosage cup included

Cherry Flavored

RELIEF OF:

• Runny Nose

• Sneezing

• Itchy, Watery Eyes

• Itchy Throat or Nose

• 4-6 Hours/Dose

• Alcohol Free

• Gluten Free

4 FL OZ (118mL)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:19.688629 · Updated: 2026-03-14T23:03:20.235753