ASPIRIN- aspirin tablet 
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.

----------

Children’s Aspirin (NSAID)

Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Use

temporarily relieves minor aches and pains

Warnings

Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

hives
asthma (wheezing)
shock
facial swelling
 
Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child
has had stomach ulcers or bleeding problems
take a blood-thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
takes more or for a longer time than directed
 
Do not use
if the child has ever had an allergic reaction to any other pain reliever / fever reducer
for at least 7 days after tonsillectomy or oral surgery
 
Ask a doctor before use if
stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has not been drinking fluids
child has lost a lot of fluid due to vomiting and diarrhea
child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
child is taking a diuretic
child has asthma
 
Ask a doctor or pharmacist before use if the child is
taking a prescription drug for diabetes, gout or arthritis
taking any other drug
under a doctor’s care for any serious condition
 
Stop use and ask a doctor if
child experiences any of the following signs of stomach bleeding:
feels faint
vomits blood
has bloody or black stools
has stomach pain that does not get better
pain gets worse or lasts more than 5 days
any new symptoms appear
redness or swelling is present in the painful area
ringing in the ears or a loss of hearing occurs
 
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

this product does not contain directions or complete warnings for adult use
administer only under adult supervision
if possible, use weight to dose, otherwise use age
repeat dose every 4 hours while symptoms last
do not give more than 5 doses in 24 hours
drink water with each dose
Weight (lbs.)Age (years)Dose

77 – 83

11 to under 12

4 – 6 tablets

66 – 76

9 to under 11

4 - 5 tablets

46 – 65

6 to under 9

4 tablets

36 – 45

4 to under 6

3 tablets

32 – 35

3 to under 4

2 tablets

under 32

under 3

ask a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

Questions or Comments

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

C:\Users\advance\Desktop\word docs - rugby\children aspirin 81 mg\Figure 1.png

NDC 0536-3297-36

Children’s Aspirin (NSAID) 11/4 gr (81 mg)
Pain Reliever

Chewable Orange Flavor

36 Tablets

Rugby Duluth, Georgia 30097

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3297
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ORANGE (UNII: 5EVU04N5QU)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code AP;009
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3297-3636 in 1 BOTTLE; Type 0: Not a Combination Product01/23/199807/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/23/199807/29/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019
 
Rugby Laboratories Inc.