DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid

Dye Free Childrens Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Dye Free Childrens Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Precision Dose, Inc., P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

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

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.

When using this product

• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• 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 (1-800-222-1222) right away.

Directions

• Use as directed per healthcare professional.
• do not take more than 6 doses in 24 hours
• take every 4 to 6 hours, or as directed by a doctor
• mL = milliliter
• find the right dose on the chart below

Age (yr)	Dose (mL)
children 6 to 11 years	5 mL to 10 mL
children 2 to 5 years	do not use unless directed by a doctor
children under 2 years	do not use

Other information

• each 5 mL contains: sodium 8 mg
• store between 20-25°C (68-77°F). Do not refrigerate.
• protect from light.
• see individual label or shipper for lot number and expiration date.

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

SPL UNCLASSIFIED SECTION

Alcohol Free, Dye Free

How Supplied

NDC: 68094-022-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC: 68094-024-62
10 mL per unit dose cup
Thirty (30) cups per shipper

QUESTIONS

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

SPL UNCLASSIFIED SECTION

Manufactured by:
PL Developments
Lynwood, CA 90262

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

LI1156 Rev. 08/18

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC: 68094-022-59

PrecisionDose™

Children's DYE FREE
diphenhydrAMINE HCl Liquid
12.5 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

NDC: 68094-024-59

PrecisionDose™

Children's DYE FREE
diphenhydrAMINE HCl Liquid
25 mg/10 mL

Delivers 10 mL, each 5 mL contains: sodium 8 mg
Alcohol Free, Protect from light, Hospital Use Only

Store between 20°-25°C (68°-77°F)
Do not refrigerate
Pkg. By: Precision Dose, Inc.
South Beloit, IL 61080
1158 R0

INGREDIENTS AND APPEARANCE

DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-022(NDC:49580-0293)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68094-022-62	3 in 1 CASE	12/27/2018
1		10 in 1 TRAY
1	NDC: 68094-022-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/27/2018

DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-024
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68094-024-62	3 in 1 CASE	12/27/2018
1		10 in 1 TRAY
1	NDC: 68094-024-59	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/27/2018

Labeler - Precision Dose, Inc. (035886746)

Establishment
Name	Address	ID/FEI	Business Operations
P & L Development, LLC		113044205	MANUFACTURE(68094-022, 68094-024)