ASPIRIN- aspirin tablet, chewable 
Rite Aid

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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Rite Aid 44-218

Active ingredient (in each tablet)

Aspirin 81 mg  [1 1/4 gr] (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:

    • headache

    • toothache

    • the common cold

    • sore throat

  • temporarily reduces fever

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 sign of Reye"s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • hives 

  • facial swelling

  • shock

  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user:

  • has had stomach ulcers or bleeding problems

  • takes a blood thinning (anticoagulant) or steroid drug

  • is age 60 or older

  • takes more or for a longer time than directed

  • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

  • has 3 or more alcoholic drinks every day while using this product

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

  • if you are allergic to aspirin or any other pain reliever/fever reducer

  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

  • stomach bleeding warning applies to user

  • user has a history of stomach problems, such as heartburn

  • user has asthma

  • user has high blood pressure, heart disease, liver cirrhosis or kidney disease

  • user takes a diuretic

  • user has lost a lot of fluid due to vomiting or diarrhea

  • user has not been drinking fluids

Ask a doctor or pharmacist before use if

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • user experiences any of the following signs of stomach bleeding:

    • vomits blood

    • has bloody or black stools

    • feels faint

    • has stomach pain that does not get better

  • an allergic reaction occurs. Seek medical help right away.

  • new symptoms occur

  • ringing in the ears or loss of hearing occurs

  • pain gets worse or lasts more than 10 days

  • pain gets worse or lasts more than 5 days in children under 12

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • drink a full glass of water with each dose

  • to be administered only under adult supervision
  • if possible, use weight to determine dose.  Otherwise use age.
Weight (lbs.) Age (years) Dosage 
under 32  children under 3consult a doctor 
32 to35 3 to under 4 2 tablets 
36 to 454 to under 6 3 tablets 
46 to 65 6 to under 9 4 tablets 
66 to 76 9 to under 11 4 to 5 tablets 
77 to 83 11 to under 12 4 to 6 tablets 
84 and over 12 and over 5 to 8 tablets 

Other information

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

  • see end flap for expiration date and lot number

Inactive ingredients

dextrates, ethylcellulose, FD&C yellow #6 aluminum lake, orange flavor, sodium saccharin, starch

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

RITE AID®

PHARMACY

$1.00

CHILDREN'S

CHEWABLE

Aspirin

ANALGESIC       LOW STRENGTH

(NSAID)

ORANGE FLAVOR

16 TABLETS - 81 mg each

Compare to the active ingredient in Bayer® Chewable Low Dose Aspirin†

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

50844    ORG031021821

DISTRIBUTED BY:

Rite Aid

30 Hunter Lane

Camp Hill, PA 17011

218 promo

ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-0218
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DEXTRATES 
ETHYLCELLULOSES 
FD&C YELLOW NO. 6 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code 44;218
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0218-21 in 1 CARTON
116 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/12/1990
Labeler - Rite Aid (014578892)

Revised: 8/2011
Document Id: ac4fe306-e45d-4855-98c9-eca227b51f92
Set id: 77cfa372-e3ad-4112-bbd1-5227342aaafd
Version: 6
Effective Time: 20110808
 
Rite Aid