cough & cold therapy for kids

cough & cold therapy for kids
SPL v3
SPL
SPL Set ID 088df369-114c-db4f-e063-6394a90acfac
Route
topical
Published
Effective Date 2023-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (4.7 g) menthol (2.6 g) eucalyptus oil (1.2 g)
Inactive Ingredients
yellow wax jojoba oil shea butter coconut oil .alpha.-tocopherol olive oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-09-14

Purpose

Organic Camphor 4.7%......................Topical Antitussive Organic Menthol 2.6%........................Topical Antitussive Organic Eucalyptus Oil 1.2%..............Topical Antitussive

Description

Organic Camphor 4.7% Organic Menthol 2.6% Organic Eucalyptus Oil 1.2%


Medication Information

Warnings

For external use only

Uses

Temporarily relieves cough associated with the common cold.

Purpose

Organic Camphor 4.7%......................Topical Antitussive

Organic Menthol 2.6%........................Topical Antitussive

Organic Eucalyptus Oil 1.2%..............Topical Antitussive

Directions

See important warnings under "When using this product"

Children 2 years and older:

  • rub on the throat and chest in a thick layer
  • cover with a warm dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • use up to 3 times daily or as directed by a doctor

Children under 2 years of age: Ask a doctor.

Other Information

Tamper-evdent. Ensure seal is intact before use.

Inactive Ingredients

Organic Beeswax, Organic Coconut Oil, Organic Jojoba Oil, Organic Olive Oil, Organic Shea Butter, Vitamin E.

Description

Organic Camphor 4.7% Organic Menthol 2.6% Organic Eucalyptus Oil 1.2%

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if

  • a cough that persists for more than 1 week, tends to recur, or is accompanied by fevrer, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 50567-7

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water. May cause splattering and result in burns.
Section 50569-3

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).
Section 50570-1

Do not use

  • by mouth
  • in nostrils
Section 51945-4

maple organics

Cough & Cold Therapy For Kids

Soothing & Calming Cough Suppressant

Net Wt. 2 oz / 56 g

Active Ingredients

Organic Camphor 4.7%

Organic Menthol 2.6%

Organic Eucalyptus Oil 1.2%


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves cough associated with the common cold.

Purpose

Organic Camphor 4.7%......................Topical Antitussive

Organic Menthol 2.6%........................Topical Antitussive

Organic Eucalyptus Oil 1.2%..............Topical Antitussive

Directions

See important warnings under "When using this product"

Children 2 years and older:

  • rub on the throat and chest in a thick layer
  • cover with a warm dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • use up to 3 times daily or as directed by a doctor

Children under 2 years of age: Ask a doctor.

Other Information (Other information)

Tamper-evdent. Ensure seal is intact before use.

Inactive Ingredients (Inactive ingredients)

Organic Beeswax, Organic Coconut Oil, Organic Jojoba Oil, Organic Olive Oil, Organic Shea Butter, Vitamin E.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • a cough that persists for more than 1 week, tends to recur, or is accompanied by fevrer, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 50567-7 (50567-7)

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water. May cause splattering and result in burns.
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).
Section 50570-1 (50570-1)

Do not use

  • by mouth
  • in nostrils
Section 51945-4 (51945-4)

maple organics

Cough & Cold Therapy For Kids

Soothing & Calming Cough Suppressant

Net Wt. 2 oz / 56 g

Active Ingredients (Active ingredients)

Organic Camphor 4.7%

Organic Menthol 2.6%

Organic Eucalyptus Oil 1.2%


Advanced Ingredient Data


Raw Label Data

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