Medpura

Medpura
SPL v4
SPL
SPL Set ID 51b32162-0c5a-4b5b-999a-34337d816603
Route
TOPICAL
Published
Effective Date 2023-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.048 g) Eucalyptus Oil (0.012 g) Menthol (0.026 g)
Inactive Ingredients
Cedar Leaf Oil Nutmeg Oil Petrolatum Pine Nut Oil Thymol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Drug Facts

Purpose

Cough suppressant and topical analgesic Cough suppressant Cough suppressant and topical analgesic


Medication Information

Purpose

Cough suppressant and topical analgesic

Cough suppressant

Cough suppressant and topical analgesic

Description

Drug Facts

Uses
  • when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associatedwith the common cold
  • when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Warnings

For external use only;avoid contact with eyes.

Directions

see important warnings under " When using this product"

  • adults and children 2 years and over
  • for cough suppression
  • rub a thick layer on throat & chest &
  • cover with a warm, dry cloth if desired
  • keep clothing loose about throat and chest to help vapors reach the nose and mouth
  • use up to three times daily or as directed by doctor
  • for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily
  • children under 2 years: do not use
Do Not Use
  • by mouth
  • in nostrils
  • with tight bandages
  • on wounds or damaged skin
Other Information
  • store at room temperature
Active Ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Inactive Ingredients

cedar wood oil, nutmeg oil, petrolatum, pine oil, thymol.

Manufactured for:

Akron Pharma Inc.

Fairfield, NJ 07004.



Call 1-877-225-6999

www.akronpharma.com

Stop Use and Ask A Doctor If
  • muscle aches and pains worsen or persist for more than 7 days or clear up occur again within few days.
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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.
Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

Structured Label Content

Uses
  • when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associatedwith the common cold
  • when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Cough suppressant and topical analgesic

Cough suppressant

Cough suppressant and topical analgesic

Warnings

For external use only;avoid contact with eyes.

Directions

see important warnings under " When using this product"

  • adults and children 2 years and over
  • for cough suppression
  • rub a thick layer on throat & chest &
  • cover with a warm, dry cloth if desired
  • keep clothing loose about throat and chest to help vapors reach the nose and mouth
  • use up to three times daily or as directed by doctor
  • for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily
  • children under 2 years: do not use
Do Not Use (Do not use)
  • by mouth
  • in nostrils
  • with tight bandages
  • on wounds or damaged skin
Other Information (Other information)
  • store at room temperature
Active Ingredients (Active ingredients)

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Inactive Ingredients (Inactive ingredients)

cedar wood oil, nutmeg oil, petrolatum, pine oil, thymol.

Manufactured for:

Akron Pharma Inc.

Fairfield, NJ 07004.



Call 1-877-225-6999

www.akronpharma.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • muscle aches and pains worsen or persist for more than 7 days or clear up occur again within few days.
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
When Using This Product, Do Not (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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

Advanced Ingredient Data


Raw Label Data

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