DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium Glycerin Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sorbitol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-05-20

Medication Information

Purpose

Antihistamine

Description

Active ingredient [in each 5 mL] Diphenhydramine HCl, USP 12.5 mg

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

Warnings

Do not use

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

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
mL = milliliter

Age (yr)	Dose (mL)
children under 6 years of age	ask a doctor
children 6 years to under 12 years of age	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.

Drug Facts

Active ingredient [in each 5 mL]

Diphenhydramine HCl, USP 12.5 mg

Other Information

each 5 mL contains: sodium 9 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
see bottom panel for lot number and expiration date

Inactive Ingredients

anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments? 1-855-274-4122

Distributed ByATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI, FL 33179

When Using This Product

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

Package Label Principal Display Panel

NDC 17856-0361-01

Compare to

Children's Benadryl^®

active ingredient*

Children's

ALLERGY

Antihistamine

diphenhydramine hydrochloride

25mg/10 mL oral solution

liquid medication

Relieves:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat

Sugar & Alcohol Free

Dye-Free Bubble Gum Flavored

NDC 17856-0361-02

Compare to

Children's Benadryl®

active ingredient*

Children's

ALLERGY

Antihistamine

diphenhydramine hydrochloride

12.5mg/5mL oral solution

liquid medication

Relieves:

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat

Sugar & Alcohol Free

Dye-Free

Bubble Gum Flavored

Ask A Doctor Before Use If the Child Has

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

Ask A Doctor Or Pharmacist Before Use If You

are taking sedatives or tranquilizers

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

Warnings

Do not use

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

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
mL = milliliter

Age (yr)	Dose (mL)
children under 6 years of age	ask a doctor
children 6 years to under 12 years of age	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.

Drug Facts

Active ingredient [in each 5 mL]

Diphenhydramine HCl, USP 12.5 mg

Other Information (Other information)

each 5 mL contains: sodium 9 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments? 1-855-274-4122

Distributed ByATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI, FL 33179

When Using This Product (When using this product)

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

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)

Package Label Principal Display Panel (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL)

NDC 17856-0361-01

Compare to

Children's Benadryl^®

active ingredient*

Children's

ALLERGY

Antihistamine

diphenhydramine hydrochloride

25mg/10 mL oral solution

liquid medication

Relieves:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat

Sugar & Alcohol Free

Dye-Free Bubble Gum Flavored

NDC 17856-0361-02

Compare to

Children's Benadryl®

active ingredient*

Children's

ALLERGY

Antihistamine

diphenhydramine hydrochloride

12.5mg/5mL oral solution

liquid medication

Relieves:

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat

Sugar & Alcohol Free

Dye-Free

Bubble Gum Flavored

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

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

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

are taking sedatives or tranquilizers

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": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "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", "Purpose": "Antihistamine", "Warnings": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Directions": "take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours mL = milliliter Age (yr) Dose (mL) children under 6 years of age ask a doctor children 6 years to under 12 years of age 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.", "Drug Facts": "Active ingredient [in each 5 mL] Diphenhydramine HCl, USP 12.5 mg", "Other information": "each 5 mL contains: sodium 9 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used see bottom panel for lot number and expiration date", "Inactive ingredients": "anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution Questions or comments? 1-855-274-4122 Distributed By ATLANTIC BIOLOGICALS CORP. 20101 N.E 16TH PLACE MIAMI, FL 33179", "When using this product": "sedatives and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur, especially in 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)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL": "NDC 17856-0361-01 Compare to Children's Benadryl ® active ingredient* Children's ALLERGY Antihistamine diphenhydramine hydrochloride 25mg/10 mL oral solution liquid medication Relieves: Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat Sugar & Alcohol Free Dye-Free Bubble Gum Flavored NDC 17856-0361-02 Compare to Children's Benadryl® active ingredient* Children's ALLERGY Antihistamine diphenhydramine hydrochloride 12.5mg/5mL oral solution liquid medication Relieves: Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat Sugar & Alcohol Free Dye-Free Bubble Gum Flavored", "Ask a doctor before use if the child has": "glaucoma a breathing problem such as emphysema or chronic bronchitis a sodium-restricted diet", "Ask a doctor or pharmacist before use if you": "are taking sedatives or tranquilizers"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information