Tiny Tot Cough Syrup
FDA Label NDC 43406-0595

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc for the product Tiny Tot Cough Syrup (NDC 43406-0595). 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, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.