Extra Strength 94.41 mg/mL
Menthol and Methyl Salicylate · OIL · Saje Natural Business Inc.
Extra Strength is a oil containing menthol and methyl salicylate at 94.41 mg/mL, taken topical. Manufactured by Saje Natural Business Inc..
Key Facts
- Brand Name
- Extra Strength
- Generic Name
- Menthol and Methyl Salicylate
- NDC Code (Product)
70983-023- Manufacturer
- Saje Natural Business Inc.
- Strength
- 94.41 mg/mL
- Dosage Form
- OIL
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Marketing Start
- 05/13/2019
Recall History
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Contract Pharmacal Corporation
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Medinatura New Mexico, inc.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
A-S Medication Solutions LLC.
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Ridge Properties, LLC
GMP Deviations: inadequate manufacturing control processes
Haleon US Holdings LLC
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
RIJ Pharmaceutical LLC
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Dosage & Administration
Directions do not take more than directed adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to acetaminophen or any of the inactive ingredients in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present 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 overdose, get medical help or cont…
Frequently Asked Questions
What is Extra Strength used for?
Extra Strength contains Menthol and Methyl Salicylate. It is a oil taken topical. Consult your doctor for specific uses.
Is Extra Strength a controlled substance?
Extra Strength is not classified as a controlled substance by the DEA.
What is the generic name for Extra Strength?
The generic name for Extra Strength is Menthol and Methyl Salicylate. There are 7 other brand versions of Menthol and Methyl Salicylate.
What is the NDC code for Extra Strength 94.41 mg/mL?
The NDC (National Drug Code) for Extra Strength 94.41 mg/mL is 70983-023, listed by Saje Natural Business Inc..