Medicated
FDA Label NDC 55319-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Medicated (NDC 55319-100). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, 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
Camphor 4.8%
Menthol 2.6%
Eucalyptus Oil 1.2%

Otc - Purpose

Purpose

Cough suppressant /topical analgesic

Cough suppressant /topical analgesic

Cough supressan

Indications & Usage

Uses: Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains

Warnings

Warnings

For external use only. Avoid contact with eyes

Otc - Do Not Use

Do not use:

  • by mouth
  • by nostrils
  • on wounds or damaged skin
  • with light bandages

Otc - Ask Doctor

Ask a doctor before use if you have

  • asthma
  • excessive phlem (mucus)
  • emphysema
  • persistent or chronic cough
  • cough associated with smoking

Otc - When Using

When using this product do not heat
  • microwave
  • use near open flame
  • add to hot water or any container where heating water may cause splattering and result in burns

Otc - Stop Use

Stop use and ask a doctor if

  • muscle aches/pain persist more than more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health profesional before use

Otc - Keep Out Of Reach Of Children

Keep out reach of children.

In case of accidental ingestion get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • see important warnings when using this product
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years older, rub a thick layer on chest and and throat or rub on sore,aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily

Other

Other information

  • Store at room temperature

    • Image Of Front Label (Front)

    Image Of Front Label (Front)

Inactive Ingredient

Inactive ingredients:

cedar leaf oil, nutmeg oil, paraffin, patrolatum, thymol, turpentine oil

Package Label.Principal Display Panel

Medicated chest rub


4 oz (113 g)




Image Of Back Label (Back)

Image Of Back Label (Back)

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