Otc - Active Ingredient
Diphenhydramine HCl 12.5 mg (in each 5 mL)
Rompe Pechito Allergy For Kids Syrup
FDA Label NDC 58593-006
14 label sections · Submitted to the FDA by Efficient Laboratories, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories, Inc. for the product Rompe Pechito Allergy For Kids (NDC 58593-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist, when using this product, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihistamine
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
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
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 right away (1-800-222-1222).
Directions
- find the right dose on chart below; mL=milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
- use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device
| age | dose |
|---|---|
| children 6 to 11 years | 5 mL (1 teaspoonful) to 10 mL (2 teaspoonful) |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Other Information
- store between 15-30°C (59-86°F)
- do not refrigerate
- product color & flavor may vary due to natural honey
- TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing
Inactive Ingredients
anhydrous citric acid, elderberry fruit extract, flavor, glycerin, honey, maltodextrin, methylparaben, potassium sorbate, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate
Questions Or Comments?
305-805-3456 Monday - Friday from 9 AM to 5 PM, EST or www.efficientlabs.com
Warnings
See the Do not use, Ask a doctor, Ask a doctor or pharmacist, When using, and Keep out of reach of children sections below.
Principal Display Panel
Rompe Pechito Allergy For Kids Label (Rompe Pechito Allergy 4oz Lbl)
Rompe Pechito Allergy For Kids Box (Rompe Pechito Allergy 4oz Box)
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