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  5. Label Information: Tiny Tot Cough Syrup

FDA Label for Tiny Tot Cough Syrup

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. OTC - PURPOSE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tiny Tot Cough Syrup Product Label

The following document was submitted to the FDA by the labeler of this product Natural Creations, Inc. 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.

Otc - Active Ingredient



ACTIVE INGREDIENTS - equal amounts of: Squilla 8X, Antimonium Tart 30C, Arsenicum Alb 30C, Belladonna 30C, Bryonia 30C, Chamomilla 30C, Cuprum Met 30C, Drosera 30C, Hepar Sulph Calc 30C, Ipecacuanha 30C, Kali Bic 30C, Kali Carb 30C, Phosphorus 30C, Pulsatilla 30C, Spongia 30C


Indications & Usage



USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**


Otc - Purpose



USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**


Dosage & Administration



DIRECTIONS: Age 0-6 years: 1/2 teaspoon up to 8 times per day. 6 years and older: 1 teaspoon up to 8 times per day.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.


Warnings



WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • A persistent cough may be a sign of a more serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied be fever, rash, or persistent headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient



INACTIVE INGREDIENTS: Acacia Gum, Citric Acid, Glycerin USP, Grape Flavor, Grape Skin Extract, Potassium Sorbate, Purified Water


Otc - Questions



QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600


References



**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Package Label.Principal Display Panel



NDC:43406-0595-4

Tiny Tot Cough Syrup

HOMEOPATHIC

4 fl oz (120mL)


* Please review the disclaimer below.