LEADER EFFERVESCENT ANTACID AND PAIN RELIEF- aspirin, citric acid, sodium bicarbonate tablet, effervescent

United States - English - NLM (National Library of Medicine)

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Active ingredient:
(in each effervescent tablet), Anhydrous citric acid 1000mg, Aspirin 325mg (NSAID)*, Sodium bicarbonate 1916mg, *Nonsteroidal anti-inflammatory drug
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anhydrous citric acid 1000mg...................Antacid Aspirin 325mg...........................................Pain reliever Sodium bicarbonate 1916mg....................Antacid for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains) ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product. ■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have a sodium-restricted diet ■ presently taking a prescription drug. Antacids may interact with certain prescription drugs. ■ taking a prescription drug for a
Authorization status:
OTC monograph final
Authorization number:
70000-0421-1

LEADER EFFERVESCENT ANTACID AND PAIN RELIEF- aspirin, citric acid, sodium

bicarbonate tablet, effervescent

Cardinal Health

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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Leader Effervescent Antacid & Pain Relief

Purpose

Anhydrous citric acid 1000mg...................Antacid

Aspirin 325mg...........................................Pain reliever

Sodium bicarbonate 1916mg....................Antacid

Active Ingredients

(in each effervescent tablet)

Anhydrous citric acid 1000mg

Aspirin 325mg (NSAID)*

Sodium bicarbonate 1916mg

*Nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by

headache or body aches and pains

■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body

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 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 ■ asthma (wheezing) ■ shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID),

which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have

had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take

other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time

than directed

Do not use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ if you are allergic

to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking

this product.

Ask a doctor before use if

■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a

diuretic ■ you have a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

■ presently taking a prescription drug. Antacids may interact with certain prescription drugs. ■ taking a

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

When using this product

do not take more than 8 tablets (adults) or 4 tablets (60 years and over) in a 24-hour period or use the

maximum dosage for more than 10 days

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding ■ feel faint ■ vomit blood ■ have

bloody or black stools

■ have stomach pain that does not get better

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

■ pain lasts for more than 10 days or gets worse

■ new symptoms occur ■ redness or swelling is present

■ ringing in the ears or a 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 the 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 right away. 1-800-222-1222

Directions

■ do not exceed recommended dosage

■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

adults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours or as directed by a

doctor

do not exceed 8 tablets in 24 hours

60 years and over: 2 tablets every 4 hours or as directed by a doctor

do not exceed 4 tablets in 24 hours

Children under 12 years: consult a doctor

Other information

each tablet contains: sodium 524 mg

■ store at room temperature (59º-86ºF)

Inactive ingredients

■ none

Questions or comments?

Call 1-888-228-6931

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cardinal Health

LEADER EFFERVESCENT ANTACID AND PAIN RELIEF

aspirin, citric acid, sodium bicarbonate tablet, effervescent

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 421

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

325 mg

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO) (BICARBONATE ION - UNII:HN1ZRA3Q20 )

SODIUM BICARBONATE

19 16 mg

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID -

UNII:XF417D3PSL)

ANHYDROUS CITRIC

ACID

10 0 0 mg

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

25mm

Flavor

Imprint Code

L421

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 421-1

36 in 1 CARTON

0 4/10 /20 19

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt343

0 4/10 /20 19

Labeler -

Cardinal Health (097537435)

Revised: 4/2019

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