publix super markets, inc. children’s allergy liquid drug facts

publix super markets, inc. children’s allergy liquid drug facts
SPL v5
SPL
SPL Set ID cc6e4e26-84f5-4003-b1eb-f0e06d3e294e
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 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 2014-02-11

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 68-77°F (20-25°C). 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

CHILDREN’S allergy liquid

DIPHENHYDRAMINE HCl 12.5 mg/ 5 mL ORAL SOLUTION

ANTIHISTAMINE

Relief of:

• Runny nose

• Sneezing

• Itchy, watery eyes

• Itchy throat or nose

CHERRY-FLAVORED LIQUID

*Compare to active ingredient in Children’s Benadryl®

ALCOHOL FREE

4-6 HOURS/DOSE

4 FL OZ (118 mL)

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
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 68-77°F (20-25°C). 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

CHILDREN’S allergy liquid

DIPHENHYDRAMINE HCl 12.5 mg/ 5 mL ORAL SOLUTION

ANTIHISTAMINE

Relief of:

• Runny nose

• Sneezing

• Itchy, watery eyes

• Itchy throat or nose

CHERRY-FLAVORED LIQUID

*Compare to active ingredient in Children’s Benadryl®

ALCOHOL FREE

4-6 HOURS/DOSE

4 FL OZ (118 mL)

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