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Chewable Aspirin by Genuine First Aid LLC

Medically reviewed on December 30, 2017

Dosage form: tablet, chewable
Ingredients: ASPIRIN 81mg
Labeler: Genuine First Aid LLC
NDC Code: 52124-0012

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.

Chewable Aspirin 81mg

Active Ingredient

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

Analgesic/antipyretic

Uses

temporary relief of minor aches, pains and headaches

to reduce fever associated with colds, sore throats, teething

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.

Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.

Do not use

if you are allergic to aspirin or any other pain relievers/fever reducers

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

for at least 7 days after a tonsillectomy or oral surgery

Ask a doctor before use if you have:

asthma

stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems

a child experiencing arthritis pain

if you are;

allergic to aspirin

taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis

Stop use and ask a doctor if:

an allergic reaction occurs, Seek medical help right away

pain or fever persists

new or unexpected symptoms occur

redness or swelling is present

ringing in ears or loss of hearing occurs

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 unborn child or complications during delivery.

Keep out of reach of children.

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

Directions

Do not use more than directed

Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours,  Do not exceed 48 tablets in 24 hours unless directed by a doctor.

Children Under 12 years: Consult a doctor.

Store at room temperature

tamper evident sealed packets

do not use any opened or torn packets

Inactive Ingredients

flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose

MADE IN USA

Distributed by GENUINE FIRST AID

600 Cleveland Str Suite 400, Clearwater, FL 33755

                                                                                            2 Tablets

GENUINE FIRST AID.

Chewable Aspirin 81mg

CHEWABLE ASPIRIN  
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
SACCHARIN 
SODIUM CATION 
SILICON DIOXIDE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
Product Characteristics
Colororange (ORANGE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeASPIRIN
Contains    
Packaging
#Item CodePackage Description
1NDC:52124-0012-12 TABLET, CHEWABLE in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/02/2010
Labeler - Genuine First Aid LLC (619609857)

 
Genuine First Aid LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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