Your browser does not support JavaScript! PAIN AND FEVER (ACETAMINOPHEN) TABLET [RUGBY LABORATORIES, INC.]
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RxNorm Names

PAIN AND FEVER (acetaminophen) tablet
[RUGBY LABORATORIES, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active Ingredients (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily reduces fever and relives minor aches and pains caused by

  • Headache
  • muscular aches
  • common cold
  • toothache
  • premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • 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.

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

  • 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

If pregnant or breast-feeding,ask a health professional before use.

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.

Directions


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 temperature

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or comments?

call 1-800-645-2158, 9 am - 5 pm ET, Monday-Friday

Package label Rugby pain & Fever

Rugby®

NDC 0536-3222-01

COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOL®

See New Warnings Information

REGULAR  STRENGTH
RELIVES

PAIN & FEVER


WITHOUT ASPIRIN
Acetaminophen USP, 325 mg

Rugby
SATISFACTION GUARANTEED OR MONEY BACK

100 TABLETS
Rugby Pain & Fever 325 mg 100 tablets label

Rugby®

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

NDC 0536-3222-10

See New Warnings Information

FOR RELIEF OF

PAIN & FEVER

Acetaminophen USP, 325 mg
Analgesic/Antipyretic

1000 tablets

Rugby
satisfaction guaranteed or money back

compare to active ingredient in extra strength tylenol®
Rugby Pain & Fever 325 mg 1000 tablets label
PAIN AND FEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-3222
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (round flat faced beveled edge) Size10mm
FlavorImprint Code GPIA325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3222-01100 in 1 BOTTLE, PLASTIC
2NDC:0536-3222-101000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34302/23/2011
Labeler - RUGBY LABORATORIES, INC. (109178264)
Registrant - Gemini Pharmaceuticals, Inc. (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc.055942270manufacture

Revised: 2/2011
 
RUGBY LABORATORIES, INC.

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