allergy

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (12.5 mg)

Inactive Ingredients

anhydrous citric acid sodium glycerin polysorbate 20 propylene glycol water sodium benzoate saccharin sodium trisodium citrate dihydrate sorbitol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph final active Since 2013-02-01

Medication Information

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

may be given every 4 to 6 hours
do not use more than 6 times in 24 hours
use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Other Information

each teaspoon contains: sodium 7 mg
store between 20°-25°C (68°-77°F)
tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive Ingredients

artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.

Description

Drug Facts

Questions?

877-434-2036

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

Do Not Use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

When Using This Product

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children.

Ask A Doctor Before Use If the Child Has

a breathing problem such as chronic bronchitis
glaucoma
a sodium-restricted diet

Active Ingredient (in Each 5 Ml = 1 Teaspoon)

Diphenhydramine, USP HCl 12.5 mg.

Principal Display Panel 118 Ml Bottle Label

ACCUDIAL _®

Children's

Allergy

Diphenhydramine HCl

Oral Solution Antihistamine

Relieves Sneezing

• Itchy, Watery Eyes

Runny Nose • Itchy Throat

Earth-Friendly

Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

Compares to Children's

Benadryl® Allergy

Dye-Free

BUBBLEGUM

FLAVOR

NDC 45014-161-04

4 FL. OZ. (118 mL)

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

may be given every 4 to 6 hours
do not use more than 6 times in 24 hours
use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Other Information (Other information)

each teaspoon contains: sodium 7 mg
store between 20°-25°C (68°-77°F)
tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive Ingredients (Inactive ingredients)

artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.

Questions?

877-434-2036

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

Do Not Use (Do not use)

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

When Using This Product (When using this product)

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children.

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

Active Ingredient (in Each 5 Ml = 1 Teaspoon) (Active ingredient (in each 5 mL = 1 teaspoon))

Diphenhydramine, USP HCl 12.5 mg.

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

ACCUDIAL _®

Children's

Allergy

Diphenhydramine HCl

Oral Solution Antihistamine

Relieves Sneezing

• Itchy, Watery Eyes

Runny Nose • Itchy Throat

Earth-Friendly

Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

Compares to Children's

Benadryl® Allergy

Dye-Free

BUBBLEGUM

FLAVOR

NDC 45014-161-04

4 FL. OZ. (118 mL)

Advanced Ingredient Data

[{"name": "Diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Anhydrous Citric Acid", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium", "unii": "9NEZ333N27", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polysorbate 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Benzoate", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Saccharin Sodium", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Trisodium Citrate Dihydrate", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbitol", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.", "Purpose": "Antihistamine", "Directions": "may be given every 4 to 6 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device.", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Questions?": "877-434-2036", "Overdose warning": "Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.", "Other information": "each teaspoon contains: sodium 7 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.", "Inactive ingredients": "artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.", "When using this product": "marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children.", "Ask a doctor before use if the child has": "a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet", "Active ingredient (in each 5 mL = 1 teaspoon)": "Diphenhydramine, USP HCl 12.5 mg.", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label": "ACCU DIAL ® Children's Allergy Diphenhydramine HCl Oral Solution Antihistamine Relieves Sneezing • Itchy, Watery Eyes Runny Nose • Itchy Throat Earth-Friendly Package! For Ages 6 yrs to under 12 yrs Tamper Evident Compares to Children's Benadryl® Allergy Dye-Free BUBBLEGUM FLAVOR NDC 45014-161-04 4 FL. OZ. (118 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information