RUGBY ACETAMINOPHEN- acetaminophen liquid 
Rugby Laboratories, Inc.

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.

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Rugby ® Pain & Fever ACETAMINOPHEN ORAL SOLUTION

Drug Facts

Active ingredient (in each 5mL)

Acetaminophen 160 mg

Purpose

Pain reliever-Fever reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

  • common cold
  • flu
  • headache
  • sore throat
  • toothache

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 drug containing acetaminophen (prescription or nonprescription). 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 appear
  • redness or swelling is present. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • find right dose on chart. If possible, use weight to dose; otherwise, use age
  • give dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours
  • use enclosed dosing cup only. Do not use with any other device.
  • mL = milliliter
WeightAgeDose
72 - 95 lbs11 years15mL
60 - 71 lbs9 - 10 years12.5mL
48 - 59 lbs6 - 8 years10mL
36 - 47 lbs4 - 5 years7.5mL
24 - 35 lbs2 - 3 years5mL
under 24 lbsunder 2 yearsask a doctor

Other information

  • each 5 mL contains: sodium 1 mg
  • store at 20 - 25°C (68 - 77°F)

Inactive ingredients

artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

Questions or comments?

1-800-645-2158

Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Rugby®

NDC 0536-0122-97

RELIEVES CHILDREN'S
Pain
&Fever
ACETAMINOPHEN
ORAL SOLUTION

CHERRY FLAVORED

SUGAR FREE
Aspirin & Alcohol Free

4 fl oz (118 mL) 160mg per 5mL

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
RUGBY  ACETAMINOPHEN
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CHERRY (UNII: BUC5I9595W)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-0122-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/28/201101/31/2021
2NDC:0536-0122-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/28/201101/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/28/201101/31/2021
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 9/2019
 
Rugby Laboratories, Inc.