Chewable Aspirin description, usages, side effects, indications, overdosage, supplying and lots more!

Chewable Aspirin

Genuine First Aid LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Chewable Aspirin 81mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

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

Purpose

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.


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 Type Human otc drug label Item Code (Source) NDC:52124-0012
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 81 mg

Inactive Ingredients

Ingredient Name Strength
FD&C YELLOW NO. 6
SACCHARIN
SODIUM CATION
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
orange (ORANGE) 11 mm ASPIRIN ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52124-0012-1 2 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-04-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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