Active Ingredient (In Each Caplet)
Acetaminophen USP, 650 mg
Acetaminophen Tablet, Extended Release
FDA Label NDC 70010-160
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Granules Pharmaceuticals Inc. for the product Acetaminophen (NDC 70010-160). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
For
Arthritis Pain label
• temporarily relieves minor aches and pains due to:
• minor pain of arthritis
• muscular aches
• backache
• premenstrual and menstrual cramps
• the common cold
• headache
• toothache
• temporarily reduces fever
For
Muscle Aches & Pain label
• temporarily relieves minor aches and pains due to:
• muscular aches
• backache
• minor pain of arthritis
• toothache
• premenstrual and menstrual cramps
• headache
• the common cold
• temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take
• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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 drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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 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 of overdose, get medical help or contact a poison control center right away.(1-800 222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
For Arthritis Pain Label
•
do not take more than directed (see overdose warning)
| adults | • take 2 caplets every 8 hours with water
• swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor |
| under 18 years
of age | • ask a doctor |
For Muscle Ache and Pain label
• do not take more than directed (see overdose warning)
| adults and children
12 years of age and over | • take 2 caplets every 8 hours with water
• swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor |
| children under
12 years | • do not use |
Other Information
• store between 20-25°C (68-77°F)
• do not use if foil inner seal is broken or missing.
Inactive Ingredients
hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments ?
Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
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