FDA Label for Xpect Acetaminophen
View Indications, Usage & Precautions
Xpect Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Cintas Corporation. 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.
Purpose
Pain reliever/Fever reducer
Keep Out Of Reach Of Children
Keep 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 right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Active Ingredients
Active ingredient (in each tablet)
• Acetaminophen 500mg……………….Pain reliever/Fever reducer
Inactive Ingredients
Corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide. May contain povidone and sodium starch glycolate.
Uses(S)
Temporarily relieves fever and minor aches and pains associated with:
• Headache
• Common cold
• Muscular aches
• Backache
• Menstrual cramps
• Toothache
• Minor arthritis pain
Warning(S)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• More than 8 tablets in 24 hours, which is the maximum daily amount.
• 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 skin reaction occurs, stop use and seek medical help right away.
Do not use
• With any other product 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 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years of age: Do not use this product; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concern.
Other Information
• Do not use if packet is torn, cut, or opened
• Store at room temperature
• Avoid excessive heat and humidity
• Single Dose
• Tamper Evident
• Non-Drowsy
• Aspirin-free
See new warnings information
Questions? 1-877-973-2811 Monday – Friday 8AM – 5PM
250 Tablets/2 Tablets per Packet
Product #111399
Xpect Acetaminophen
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