ALKA-SELTZER EXTRA STRENGTH- anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

Bayer HealthCare LLC.

INN (International Name):

ANHYDROUS CITRIC ACID

Composition:

ANHYDROUS CITRIC ACID 1000 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

for the temporary relief of: - heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains - upset stomach with headache from overindulgence in food or drink - headache, body aches, and pain alone

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALKA-SELTZER EXTRA STRENGTH- ANHYDROUS CITRIC ACID, SODIUM
BICARBONATE,
AND ASPIRIN GRANULE, EFFERVESCENT
BAYER HEALTHCARE LLC.
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ALKA-SELTZER EXTRA STRENGTH
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_TABLET)_
_PURPOSE_
Anhydrous citric acid 1000 mg
Antacid
Aspirin 500 mg
Analgesic
Sodium bicarbonate (heat-
treated) 1985 mg
Antacid
USES
for the temporary relief of:
heartburn, acid indigestion, and sour stomach when accompanied with
headache or
body aches and pains
upset stomach with headache from overindulgence in food or drink
headache, body aches, and pain alone
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 an 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 are allergic to aspirin or any other pain reliever/fever
reducer
if you have ever had an allergic reaction to this product or any of
its ingredients
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 asthma
you have a sodium-restricted diet
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
presently taking a prescription drug. Ant