flanex 248.001/248ai

flanex 248.001/248ai
SPL v3
SPL
SPL Set ID 3622e072-2784-c57e-e063-6394a90a8217
Route
topical
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (26 mg) camphor (synthetic) (48 mg) eucalyptus oil (12 mg)
Inactive Ingredients
cedar leaf oil nutmeg oil petrolatum thymol turpentine oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-27

Purpose

Cough suppressant & topical analgesic

Description

Failure to follow these warnings could result in serious consequences.


Medication Information

Warnings

For external use only: avoid contact with eyes.

Uses
  • on chest & throat, temporarily relieves cough due to the common cold
  • on muscles and joints, temporarily relieves minor aches and pains
Purpose

Cough suppressant & topical analgesic

Directions

see important warnings under “When using this product”

  • adults & children 2 yrs & over:
  • rub a thick layer on chest & throat or rub on sore aching muscles
  • cover with a warm, dry cloth if desired
  • keep clothing loose about throat/chest to help vapors reach the nose/mouth
  • repeat up to three times per 24 hours or as directed by doctor
  • children under 2 years of age: ask a doctor
Other Information
  • store at room temperature
Inactive Ingredients

cedarleaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol

Description

Failure to follow these warnings could result in serious consequences.

Principal Display Panel

NDC 27854-399-00

FLANAX

CHEST RUB

Cough Suppressant / Topical Analgesic

NET WT 1.76 oz (50 g)

Warning

Failure to follow these warnings could result in serious consequences.

Disclaimer

Keep carton for full information

Do Not Use
  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin
Adverse Reaction

Made in the USA with US and foreign components.

27854-399-00

Distributed by: Belmora LLC

3101 Wilson Blvd. Suite 500, Arlington, VA 22201

1 888 779 2877 M-F (L-V) 9AM-5PM EST

Active Ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Tamper Evident Statement

Tamper evident: sealed under cap for your protection.

Stop Use and Ask A Doctor If
  • muscle aches and pains persist more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

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

Warnings

For external use only: avoid contact with eyes.

Uses
  • on chest & throat, temporarily relieves cough due to the common cold
  • on muscles and joints, temporarily relieves minor aches and pains
Purpose

Cough suppressant & topical analgesic

Directions

see important warnings under “When using this product”

  • adults & children 2 yrs & over:
  • rub a thick layer on chest & throat or rub on sore aching muscles
  • cover with a warm, dry cloth if desired
  • keep clothing loose about throat/chest to help vapors reach the nose/mouth
  • repeat up to three times per 24 hours or as directed by doctor
  • children under 2 years of age: ask a doctor
Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

cedarleaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol

Principal Display Panel

NDC 27854-399-00

FLANAX

CHEST RUB

Cough Suppressant / Topical Analgesic

NET WT 1.76 oz (50 g)

Warning

Failure to follow these warnings could result in serious consequences.

Disclaimer

Keep carton for full information

Do Not Use (Do not use)
  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin
Adverse Reaction

Made in the USA with US and foreign components.

27854-399-00

Distributed by: Belmora LLC

3101 Wilson Blvd. Suite 500, Arlington, VA 22201

1 888 779 2877 M-F (L-V) 9AM-5PM EST

Active Ingredients (Active ingredients)

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Tamper Evident Statement

Tamper evident: sealed under cap for your protection.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • muscle aches and pains persist more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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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