365 Everyday Value Be Well Cough Ease For Kids Syrup
FDA Label NDC 42681-9033

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wfm Private Label, Lp for the product 365 Everyday Value Be Well Cough Ease For Kids (NDC 42681-9033). 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 - do not use, dosage & administration, inactive ingredient, how supplied, otc - purpose, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Antimonium tartaricum 6C
Bryonia alba 3C
Coccus cacti 3C
Drosera rotundifolia 3C
Ipecacuanha 3C
Pulsatilla 6C
Rumex crispus 6C
Spongia tosta 3C
Sticta pulmonaria 3C

Indications & Usage

Temporary relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Helps loosen phlegms (mucus) and thin bronchial secretions to make coughs more productive.

Otc - Do Not Use

Do not use if seal at base of cap is broken or missing.

Dosage & Administration

Children 2 to 12 years 1 teaspoon every 2 hours

Younger than 2 years of age not recommended

Inactive Ingredient

citric acid, honey, purified water, sodium benzoate, sucrose

How Supplied

125 Ml

Otc - Purpose

Antimonium tartaricum 6C  Helps loosen thick mucus
Bryonia alba 3C  Relieves dry and painful cough
Coccus cacti 3C  Relieves cough associated with a tickling in the throat
Drosera rotundifolia 3C  Relieves barking cough worse at night
Ipecacuanha 3C Relieves cough associated with nausea
Pulsatilla 6C  Relieves wet cough during the day becoming worse at night
Rumex crispus 6C Relieves dry cough triggered by cold air
Spongia tosta 3C Relieves dry, croupy and barking cough
Sticta pulmonaria 3C Relieves nighttime hacking cough

Storage And Handling

Store at 68-77O F (20-25O C)

Otc - Ask Doctor

Ask a doctor before use if he child has

Cough that occurs with too much phlegm (mucus)

Cough that last or is chronic such as occurs with asthma, chronic bronchitis or emphysema.



Otc - Stop Use

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be a sign of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding


Otc - When Using


Drug Interactions


Warnings


Principle Display Panel

Package images

4.2 Oz Box (Box42)

4.2 Oz Box (Box42)

6.7 Oz Box (Box67)

6.7 Oz Box (Box67)

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