Active Ingredient (In Each 2.5 Ml)
Guaifenesin 50 mg
Rompe Pechito Ex For Kids Syrup
FDA Label NDC 58593-007
12 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 Ex For Kids (NDC 58593-007). 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 active ingredient (in each 2.5 ml), purpose, uses, ask a doctor before use if the child has, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Ask A Doctor Before Use If The Child Has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough, such as occurs with asthma or chronic bronchitis.
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not give more than 6 doses in any 24 hours period
- shake well before use
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
| age | dose |
|---|---|
| children 6 to under 12 years of age | 5 mL every 4 hours |
| children 4 to under 6 years of age | 2.5 mL every 4 hours |
| children under 4 years of age | do not use |
Other Information
- store this product between 15 to 30 °C (59 to 86 °F)
- do not refrigerate
- product color & flavor may vary due to the natural honey and elderberry fruit extract
Tamper-Evident Feature: do not use this product if printed security seal is torn, broken or missing.
Inactive Ingredients
citric acid, elderberry fruit extract, flavor, glycerin, honey, maltodextrin, methylparaben, potassium sorbate as a preservative, 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, and Keep out of reach of children sections below.
Principal Display Panel
Label (Rompe Pechito Ex 4oz Lbl 1)
Box (Rompe Pechito Ex 4oz Box 1)
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