Children's Pain & Fever Acetaminophen Oral Suspension

Childrens Pain and Fever Acetaminophen by

Drug Labeling and Warnings

Childrens Pain and Fever Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Rugby. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS PAIN AND FEVER ACETAMINOPHEN- acetaminophen suspension 
Rugby

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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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

Allergy alert

acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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
Warning

For use with
enclosed
syringe

Principal Display Panel
CHILDRENS PAIN AND FEVER ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-3606
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
Cherry (UNII: BUC5I9595W)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Corn Syrup (UNII: 9G5L16BK6N)  
Glycerin (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
Sorbitol (UNII: 506T60A25R)  
Xanthan Gum (UNII: TTV12P4NEE)  
FD&C red no. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY (Wild Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-3606-9660 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/201611/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/16/201611/30/2019
Labeler - Rugby (079246066)

Revised: 12/2019
Document Id: b9a4cf2d-61e8-4c4c-863d-383a65ae39cc
Set id: fd6d954e-88f6-4490-852d-91ef1e234d5c
Version: 4
Effective Time: 20191231
 
Rugby