FDA Label for Allergy Relief Diphenhydramine Hcl
View Indications, Usage & Precautions
Allergy Relief Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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.
Drug Facts
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•runny nose •itchy,watery eyes •sneezing •itching of the nose or throat temporarily relieves these symptoms due to the common cold: •runny nose •sneezing
Warnings
Do not use •to make a child sleepy
•with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
•a breathing problem such as emphysema or chronic bronchitis •glaucoma
•difficulty in urination due to enlargement to the prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
•marked drowsiness may occur
•avoid alcoholic beverages
•alcohol, sedatives, and tranquilizers may increase drowsiness
•use caution when driving a motor vehicle or operating machinery
•excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
•take every 4 to 6 hours, or as directed by a doctor
•do not take more than 6 doses in 24 hours
| adults and children 12 years and older | 1 to 2 softgels |
| children 6 to under 12 years | 1 softgel |
| children under 6 years | do not use |
Other Information
•store at 25°C (77°F) in a dry place
•protect from light, heat and moisture
Inactive Ingredients
edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution
Questions Or Comments?
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Packaging
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