FDA Label for Teeny Tummy Gas Relief Drops

View Indications, Usage & Precautions

Teeny Tummy Gas Relief Drops Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma. 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 0.3 Ml)



Simethicone 20 mg


Purpose



Antigas


Uses



relieves the symptoms referred to as gas


Directions



• shake well before using
• all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
• do not exceed 12 doses per day
• fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
• 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 on bottle

Age (years)

Weight (lbs)

Dose

infants under 2

under 24

0.3 mL

children over 2

over 24

0.6 mL


Other Information



  • TAMPER-EVIDENT: Do not use if printed seal under cap is broken or punctured
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive Ingredients



Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.


Questions Or Comments ?



Call toll-free 1-877-225-6999.

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com


Package Label.Principal Display Panel




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