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CHILDRENS PAIN AND FEVER ACETAMINOPHEN - acetaminophen suspension 
Rugby

Children's Pain & Fever Acetaminophen Oral Suspension

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever / Fever Reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

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

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

Sore throat warning

If sore throat is severe, lasts for more than 2 days or 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.

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

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
  • redness or swelling is present
  • any new symptoms appear

These could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • shake well before using
  • if possible, use weight to dose; otherwise use age
  • use only with enclosed syringe. Do not use with any other dosing device
  • push air out of syringe. Firmly push syringe into bottle opening.
  • turn bottle upside-down and pull syringe to the correct dose
  • dispense liquid slowly into child's mouth, towards inner cheek
  • give dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours

24-35 lbs (2-3 years): 5 mL

Under 24 lbs (under 2 years): ask a doctor

Other information

store at at 20°-25° C (68°-77° F)

Inactive ingredients

Artificial flavor, citric acid anhydrous, corn syrup, FD&C Red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

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

Pain & Fever Acetaminophen Oral Suspension is distributed by Rugby Laboratories, Inc.

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 0536-3606-96
ASPIRIN & ALCOHOL FREE

COMPARE TO
ACTIVE INGREDIENT IN
INFANTS' TYLENOL
®*

Rugby®

RELIEVES CHILDREN'S
Pain
& Fever

Acetaminophen Oral Suspension
160 mg/5 mL
Pain Reliever - Fever Reducer
CHERRY FLAVORED
2 fl oz (60 mL)

See New
Dosing Directions

For use with
enclosed
syringe

• SATISFACTION GUARANTEED •
Rugby
OR YOUR MONEY BACK

Principal Display Panel

CHILDRENS PAIN AND FEVER ACETAMINOPHEN 
acetaminophen  suspension
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0536-3606
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Cherry  
Citric Acid Monohydrate  
Corn Syrup  
Glycerin  
CELLULOSE, MICROCRYSTALLINE  
CARBOXYMETHYLCELLULOSE SODIUM  
Propylene Glycol  
Water  
Sodium benzoate  
Sucralose  
Sorbitol  
Xanthan Gum  
FD&C red no. 40  
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY (Wild Cherry) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0536-3606-96 60 mL In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 08/24/2012

Labeler - Rugby (109178264)
Revised: 08/2012Rugby