FDA Label for Aurophen Regular Strength
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER HAS
- 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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 MG (100 TABLETS BOTTLE CARTON)
Aurophen Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. 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.
Drug Facts
Active ingredient (in each tablet)
Acetaminophen USP 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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, which is the maximum daily amount
- 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 you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If The User Has
liver disease
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 in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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, unless directed by a doctor
- 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 doctor
adults and children 12 years and over | |
children 6 years to under 12 years | |
children under 6 years | ask a doctor |
Other Information
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is open or if printed foil seal under cap is torn or missing.
Inactive Ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate (maize), pregelatinized starch, sodium starch glycolate, talc
Questions Or Comments?
1-800-632-6900
Distributed by: THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel 325 Mg (100 Tablets Bottle Carton)
COMPARE TO the active ingredient of NDC 30142-184-21
REGULAR STRENGTH TYLENOL® TABLETS *See top panel
Kroger®
Regular Strength
Acetaminophen Tablets
325 mg
Pain Reliever/Fever Reducer
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
actual
size
100 TABLETS
325 mg EACH
* Please review the disclaimer below.