FDA Label for Fridababy Children Allergy Relief Diphenhydramine Hcl 12.5mg Per 5ml Vial , 15ct
View Indications, Usage & Precautions
Fridababy Children Allergy Relief Diphenhydramine Hcl 12.5mg Per 5ml Vial , 15ct Product Label
The following document was submitted to the FDA by the labeler of this product Fridababy Llc. 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.
Active Ingredient (In Each 5Ml)
Diphenhydramine HCL 12.5mg
Purpose
Antihistamine
Uses
Temporarily relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
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 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 any sedatives or tranquilizers
When Using This Product
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ sedatives and tranquilizers may increase the drowsiness effect
Overdosage
In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
■ this product does not contain directions or complete warnings for adult use
■ give the recommended number of vials below following the instructions: 1. Tap the vial to eliminate air bubbles; 2. Twist the top of the vial off; 3. Squeeze the liquid into child’s mouth.
■ empty each Single Use Vial required of all liquid when dosing.
■ do not give more than 6 doses in 24 hours
Dosing chart
| Age (years) | Dose |
| 6-11 years | 1-2 Single Use Vial (5 mL each) every 4 – 6 hours. Do not exceed 12 vials in 24 hours |
Other Information
■ Each Single Use Vial contains 16mg of sodium
■ Store at 68-77°F (20-25°C)
■ Tamper Evident: do not use if top flap of carton is open. Do not use if any vial is open or broken.
Inactive Ingredients
citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, trisodium citrate dihydrate, xanthan gum.
Questions Or Comments?
1-833-WTF-FRIDA (1-833-983-3743)
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