FDA Label for Leader Acetaminophen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Leader Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 (In Each Tablet)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
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
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours• child takes more than 5 doses in 24 hours• taken with other drugs containing acetaminophen• adult has 3 or more alcoholic drinks every day while using this product• skin reddening• blisters• rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 the user has ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If The User
• has liver disease• is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If The User Is
taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
• pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)• 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
• do not take more than directed (see overdose warning)• take 2 tablets every 4 to 6 hours while symptoms last• do not take more than 10 tablets in 24 hours• do not use for more than 10 days unless directed by a doctor• take 1 tablet every 4 to 6 hours while symptoms last• do not take more than 5 tablets in 24 hours• do not use for more than 5 days unless directed by a
adults and children 12 years and over | ||
children 6-11 years | ||
children under 6 years | ask a doctor |
Inactive Ingredients
croscarmellose sodium*, povidone, pregelatinized starch, stearic acid
*may contain this ingredient
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Regular Strength
Acetaminophen Tablets, 325 mg
Pain Reliever / Fever Reducer
Aspirin Free
COMPARE TO REGULAR STRENGTH TYLENOL® TABLETS active ingredient
Actual Size
100 TABLETS
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