Label: PAIN AND FEVER- acetaminophen tablet
- NDC Code(s): 55154-6814-9
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 0536-3222
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
If you are a consumer or patient please visit this version.
- Active Ingredients (in each tablet)
Acetaminophen USP, 325 mgClose
Pain reliever/fever reducer
Relieves Pain & Fever without Aspirin
Regular Strength Tablets
See New Warnings InformationClose
temporarily reduces fever and relives minor aches and pains caused by
- muscular aches
- common cold
premenstrual and menstrual cramps
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours,which is the maximum daily amount
- child takes more than 5 tablets 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
Do not use
with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Stop use and ask a doctor if
- adult's pain gets worse or lasts more than 10 days
child's pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
Keep out of reach of children
In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Adults and children 12 years and over
1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours.
Children 6 to 11 years
1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours.
Children under 6 years
do not use
- Other information
store at room temperatureClose
- Inactive Ingredients
pregelatinized corn starch, povidone, sodium starch glycolate, stearic acidClose
- Questions or comments?
call 1-800-645-2158, 9 am - 5 pm ET, Monday-Friday
COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOLR*
*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark TylenolR. Rugby Pain & Fever is distributed by Rugby Laboratories, Inc.
Duluth, Georgia 30097
Zanesville, OH 43701Close
- Principal Display Panel
PAIN & FEVER
Acetaminophen USP, 325 mg tablets
- Principal Display Panel
PAIN & FEVER
325 mg tabletsClose
- INGREDIENTS AND APPEARANCE
PAIN AND FEVER
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-6814(NDC:0536-3222) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN POVIDONES SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID Product Characteristics Color white Score no score Shape ROUND (round flat faced beveled edge) Size 10mm Flavor Imprint Code GPIA325 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-6814-9 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/23/2011 Labeler - Cardinal Health (188557102) Establishment Name Address ID/FEI Business Operations Cardinal Health 188557102 REPACK(55154-6814)