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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

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

Summary of Product characteristics

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 a