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

Description

Failure to follow these warnings could result in serious consequences.

Purpose

Cough suppressant & topical analgesic


Medication Information

Purpose

Cough suppressant & topical analgesic

Description

Failure to follow these warnings could result in serious consequences.

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

Failure to follow these warnings could result in serious consequences.

Warnings

For external use only: avoid contact with eyes.

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
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

Other Information
  • store at room temperature
Active Ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

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)

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

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

Warning

Failure to follow these warnings could result in serious consequences.

Warnings

For external use only: avoid contact with eyes.

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
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

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)

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)

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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