Acetaminophen 10 mg/mL
Acetaminophen · INJECTION, SOLUTION · REMEDYREPACK INC.
Acetaminophen is a injection, solution containing acetaminophen at 10 mg/mL, taken intravenous. Manufactured by REMEDYREPACK INC..
Key Facts
- Brand Name
- Acetaminophen
- Generic Name
- Acetaminophen
- NDC Code (Product)
70518-4184- Manufacturer
- REMEDYREPACK INC.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA210969
- Marketing Start
- 09/24/2024
Recall History
Novartis Consumer Health
Defective container: products are packaged in pouches which may not have been fully sealed
ULTRAtab Laboratories, Inc.
CGMP Deviations
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Global Corporation
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
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.
Aidapak Services, LLC
Labeling: Label Mixup: ACETAMINOPHEN, CHEW Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD49423_1, EXP: 5/16/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003101, EXP: 6/13/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_1, EXP: 5/8/2014; TACROLIMUS,
Watson Laboratories Inc
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
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.
ULTRAtab Laboratories, Inc.
CGMP Deviations
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 • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps • temporarily reduces fever
Dosage & Administration
Directions • do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use 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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you have ever had an allergic reaction to this product or any of its ingredients 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 • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • 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. Overdose warning: In case o…
Frequently Asked Questions
What is Acetaminophen used for?
Acetaminophen contains Acetaminophen. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Acetaminophen a controlled substance?
Acetaminophen is not classified as a controlled substance by the DEA.
What is the generic name for Acetaminophen?
The generic name for Acetaminophen is Acetaminophen. There are 11 other brand versions of Acetaminophen.
What is the NDC code for Acetaminophen 10 mg/mL?
The NDC (National Drug Code) for Acetaminophen 10 mg/mL is 70518-4184, listed by REMEDYREPACK INC..
Other Acetaminophen Dosages
Other Acetaminophen Brands
See all →- acetaminophen500 mg/172162-2163
- Combogesic325 mg/172260-129
- basic care nighttime severe cold and flu650 mg/30mL72288-189
- basic care migraine relief250 mg/172288-374
- basic care nighttime cold and flu650 mg/30mL72288-459
- Basic Care Dual Action250 mg/172288-530
- basic care infants pain and fever160 mg/5mL72288-590
- basic care acetaminophen650 mg/172288-634
- AMAZON BASIC CARE ACETAMINOPHEN650 mg/172288-698
- basic care nighttime severe cold and flu325 mg/172288-721
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)