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Pain and Fever by RUGBY LABORATORIES

Medically reviewed on Jan 13, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: RUGBY LABORATORIES
NDC Code: 0536-3218

Disclaimer: 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.

Rugby Pain & Fever (Acetaminophen 500 mg) Captabs

Drug Facts

Active ingredient (in each captab)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses

  • temporarily reduces fever and relieves minor aches and pains caused by
  • headache
  • muscular aches
  • common cold
  • toothache
  • backache
  • premenstrual and menstrual cramps
  • minor pain of arthritis

Warnings

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

  • more than 4,000 mg acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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 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 you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms appear

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)

adults and children 12 years and over:

  • take 2 captabs every 6 hours while symptoms last
  • do not take more than 6 captabs in 24 hours unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information store at room temperature

Inactive ingredients hypromellose, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or comments? Call 1-800-645-2158

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed By: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Rugby®
NDC 0536-3218-01
EXTRA STRENGTH
Pain & Fever

Acetaminophen 500 mg each
100 CAPTABS

PAIN AND FEVER 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3218
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
HYPROMELLOSES 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Capsule shaped Tablet) Size17mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3218-01100 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:0536-3218-101000 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/23/2011
Labeler - RUGBY LABORATORIES (079246066)

 
RUGBY LABORATORIES

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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