FDA Label for Acetamax
View Indications, Usage & Precautions
Acetamax Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Acetaminophen 500 mg
Purpose
Pain reliever/ Fever Reducer
Uses
temporarily relieves minor aches and pains due to:
▪ headache
▪ backache
▪ toothache
▪ the common cold
▪ minor pain of arthritis
▪ muscular aches
▪ premenstrual and menstrual cramps
• temporarily reduces fever
Warnings
Alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/ fever reducers.
Acetaminophen may cause liver damage.
Do not use with any other product containing acetaminophen
Ask a doctor before use if you have
• a sodium-restricted diet
• any liver, kidney, or heart disease
• high blood pressure
Ask a doctor or pharmacist before use if you are
• allergic or sensitive to any tablet ingredients
• pregnant, breastfeeding or may become pregnant
When using this product
• do not exceed the recommend dosage
Stop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days.
If pregnant, may become pregnant, or breastfeeding, ask a health professional before use.
Keep This And All Medication Out Of Reach Of Children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• do not take more than directed (see overdose warning)
Adults and children 12 years and over
• take two tablets fully dissolved in 8 oz of water every 4 to 6 hours as needed.
• do not take more than 8 tablets in 24 hours.
• do not use more than 10 days unless directed by a doctor.
Children under 12 years do not use this adult product; this will provide more than the dose (overdose) of pain reliever and may cause liver damage.
Other Information
Each tablet contains:
Sodium 192 mg.
Store at room temperature 68 F-77 F (20oC-25oC).
Inactive Ingredients
anhydrous citric acid, dimethicone, docusate sodium, flavors, ginger oil, lemongrass oil, mannitol, polyethylene glycol 6000, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium chloride, sodium citrate, sucralose, sucrose.
* Please review the disclaimer below.