FDA Label for Dye Free Childrens Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- HOW SUPPLIED
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 5 ML CUP LABEL
- PRINCIPAL DISPLAY PANEL - 10 ML CUP LABEL
Dye Free Childrens Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Precision Dose, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Alcohol Free, Dye Free
Manufactured by:
PL Developments
Lynwood, CA 90262
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
LI1156 Rev. 08/18
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
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
Otc - Ask Doctor/Pharmacist
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
Otc - 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 (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
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
Otc - Questions
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
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
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