Chewable Aspirin 81mg

Chewable Aspirin 81mg
SPL v13
SPL
SPL Set ID 785e913e-1780-4fd4-8428-d83c26fe810c
Route
ORAL
Published
Effective Date 2010-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Saccharin Sodium Cation Silicon Dioxide Starch, Corn Stearic Acid Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: ASPIRIN Shape: round Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-02

Description

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

Purpose

Analgesic/antipyretic


Medication Information

Purpose

Analgesic/antipyretic

Description

MADE IN USA



Distributed by GENUINE FIRST AID



600 Cleveland Str Suite 400, Clearwater, FL 33755

Uses

temporary relief of minor aches, pains and headaches

to reduce fever associated with colds, sore throats, teething

Section 44425-7

Store at room temperature



tamper evident sealed packets



do not use any opened or torn packets

Section 51945-4

                                                                                            2 Tablets



GENUINE FIRST AID.



Chewable Aspirin 81mg

Section 53414-9

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.

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.

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.

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

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

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

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

Keep Out of Reach of Children.

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

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


Structured Label Content

Uses

temporary relief of minor aches, pains and headaches

to reduce fever associated with colds, sore throats, teething

Description (34089-3)

MADE IN USA



Distributed by GENUINE FIRST AID



600 Cleveland Str Suite 400, Clearwater, FL 33755

Section 44425-7 (44425-7)

Store at room temperature



tamper evident sealed packets



do not use any opened or torn packets

Section 51945-4 (51945-4)

                                                                                            2 Tablets



GENUINE FIRST AID.



Chewable Aspirin 81mg

Section 53414-9 (53414-9)

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.

Purpose

Analgesic/antipyretic

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.

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.

Do Not Use (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

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

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

Stop Use and Ask A Doctor If: (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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have: (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


Advanced Ingredient Data


Raw Label Data

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