PAIN AND FEVER- acetaminophen tablet, chewable 
A-S Medication Solutions

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Rugby Pain & Fever APAP Chewable Tablets

SAVE CARTON FOR COMPLETE DRUG FACTS

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purposes

Pain Reliever/Fever Reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
  • temporarily reduces fever.

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease.

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product,do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 days
  • 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.

Keep out of reach of children.

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or warnings for adult use.
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
WeightAgeDosage
Under 24 lbsUnder 2 yearsAsk a doctor
24-35 lbs2-3 years2 tablets
36-47 lbs4-5 years3 tablets
48-59 lbs6-8 years4 tablets
60-71 lbs9-10 years5 tablets
72-95 lbs11 years6 tablets

Other information

  • Phenylketonurics: Contains Phenylalanine 14 mg per tablet
  • Store at room temperature in a dry place

Inactive ingredients Aspartame, Colloidal Silicon Dioxide, D&C Red #27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural and Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

Questions or comments?

Call 1-800-645-2158

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

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

HOW SUPPLIED

Product: 50090-3463

Acetaminophen

Label Image
PAIN AND FEVER 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3463(NDC:0536-1014)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
AKA218 (UNII: 2LRS185U6K)  
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SILICA (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorpinkScoreno score
ShapeROUND (ROUND BICONVEX TABLET) Size10mm
FlavorBERRY (Natural and Artificial) Imprint Code 1G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-3463-01 in 1 CARTON05/24/201805/31/2021
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/01/201305/31/2021
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-3463)

Revised: 4/2025
Document Id: f7e32763-5cb5-4487-b234-f5e0ad54dc0e
Set id: 4cf5a720-be5c-464d-b117-faeb06e3b11e
Version: 5
Effective Time: 20250415
 
A-S Medication Solutions