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| Product NDC Code | 24286-1533 | ||||
|---|---|---|---|---|---|
| Drug Name | Quita colicos gas relief drops |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 198857 | ||||
| Application Number | M002 | ||||
| Labeler Name | DLC Laboratories, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 0.3 mL) Simethicone 20 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. only use the enclosed dropper. Fill dropper to the recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek. all dosages may be repeated as needed, after meals and at bedtime or as directed by a doctor do not exceed 12 doses per day dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids clean dropper well after each use and replace original cap mL = milliliter
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, hydroxypropyl methylcellulose, maltitol, natural flavor, purified water USP, sodium benzoate, sodium citrate, xanthan gum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.
Purpose
Information about the drug product’s indications for use.Purpose Antigas
Spl product data elements
Usually a list of ingredients in a drug product.QUITA COLICOS Gas RELIEF Drops Simethicone CITRIC ACID MONOHYDRATE HYPROMELLOSE, UNSPECIFIED MALTITOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM XANTHAN GUM DIMETHICONE DIMETHICONE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box De La Cruz ® Baby Gas Relief Drops Gotas Quita Cólicos ® Simethicone — ANTIGAS — Safe for newborns & infants No alcohol, No dyes, No saccharin Up To 100 Doses NATURAL CHERRY FLAVOR 1 FL OZ (30 mL) QuitaColicos-2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
INFANTS (under 2 years): 0.3 mL CHILDREN (over 2 years): 0.6 mL AGE (years) WEIGHT (lbs.) DOSE INFANTS under 2 Under 24 lbs. 0.3 mL CHILDREN over 2 More than 24 lbs. 0.6 mL Image
Manufactured by : De La Cruz Products A Division of DLC Laboratories, Inc. Paramount, CA 90723 USA
| AGE (years) | WEIGHT (lbs.) | DOSE |
|---|---|---|
| INFANTS under 2 | Under 24 lbs. | 0.3 mL |
| CHILDREN over 2 | More than 24 lbs. | 0.6 mL |
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-800-858-3889
Storage and handling
Information about safe storage and handling of the drug product.Other information do not use if printed bottle wrap is missing or broken store at room temperature do not freeze see bottom panel for lot number and expiration date
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API